Maintenance & Repair

Novem Medical is a contract manufacturing and assembly company serving the medical device industry. The company operates under the parent entity The Primary Companies, which also includes Primary Packaging Resources (custom medical device packaging solutions) and B-Safe (PPE supplier). Novem Medical specializes in contract manufacturing, custom assembly, and production services exclusively for medical device manufacturers. B-Safe division manufactures and supplies personal protective equipment including disposable face masks, disposable gloves, hair bouffants, and shoe covers. The company holds ISO certifications for medical devices and quality management systems, and maintains minority business enterprise (MBE) certification. Primary Packaging Resources provides decades of expertise in developing and producing custom packaging solutions for medical devices. The combined entity serves as a vertically integrated supplier capable of handling packaging, manufacturing, assembly, and PPE needs for medical device companies. The organization is positioned to support OEM partners requiring contract manufacturing, packaging design and production, and PPE procurement.

Prospect Life Sciences is a medical device development and contract manufacturing partner headquartered in Westminster, Colorado. The company provides integrated end-to-end services spanning research & design (R&D), product development (NPI), manufacturing transfer, and full-scale production. Core capabilities include concept validation, prototyping, design history file (DHF) creation, verification and validation (V&V) testing, process validation (IQ/OQ/PQ), supply chain establishment, and scalable manufacturing with facilities in both the USA and Costa Rica. The company is ISO 13485:2016 certified and FDA registered, operating under 21 CFR 820 quality system regulations. Prospect serves early-stage innovators, academic spin-outs, and established medical device companies across multiple therapeutic areas, including GI endoscopy, spinal implants, surgical instruments, diagnostic kitting, wheelchair mobility devices, dental instruments, and electro-medical devices. The firm bridges the "Valley of Death" between product development and commercial manufacturing, providing hands-on project management, regulatory guidance for FDA clearance and CE marking, and quality system implementation support. Manufacturing capabilities include precision assembly, kitting, fulfillment, and sterile processing (including 503B pharmaceutical outsourcing). The company emphasizes flexibility, responsiveness, and risk mitigation throughout the product lifecycle.

MDD Options is a medical device distribution and logistics services provider that operates a hybrid sales model for medical device manufacturers. The company merges distributor capabilities with third-party logistics (3PL) expertise to accelerate manufacturer revenue while allowing manufacturers to retain direct customer relationships and sales control. MDD Options manages backend business processes including state regulatory registrations (up to 26 states), sales tax compliance across 46 states, supplier credentialing and healthcare system access, and real-time customer data reporting for post-market clinical follow-up (PMCF). The company serves both domestic and foreign medical device manufacturers, offering services as U.S. Agent and Initial Importer for foreign entities with FDA 510(k), PMA, or exempt classifications. Additional services include corporate entity setup (Delaware LLC/Corporation), introductions to MedTech-specialized attorneys, accountants, risk managers, and recruiters through a fixed-fee "Speed Dial" offering. MDD Options operates approximately 1 million square feet of storage through owned and subcontracted 3PL partners and supports multiple sales channels including direct-to-consumer, hospital/healthcare provider, and software-based models. The company does not provide field clinical engineers, FDA regulatory approval assistance, or certain DME direct-to-patient distribution in specific states.

Makromed, Inc. is a quality management system (QMS) software and regulatory affairs (RA) consulting firm serving the medical device, diagnostic, pharmaceutical, nutraceutical, and biotechnology industries. The company offers a comprehensive suite of cloud-based QMS software modules including InfoPV (Process/Test Method Validation), InfoSQA (Software Validation), InfoMed (Complaints/Adverse Events Management), InfoCAPA (Corrective/Preventive Actions), InfoAudit (Internal and Supplier Audits), and InfoTrain (Employee Training). In addition to software, Makromed provides specialized consulting services in process and test method validation, software validation, risk management, statistical techniques and biostatistics, design controls, CAPA implementation, Six Sigma tools, and regulatory compliance auditing. The firm also offers FDA-focused training through MyFDAcademy.com, an interactive online platform covering QMS and RA topics. With ISO 13485:2016 certification, Makromed serves as a trusted partner for companies navigating FDA QSR, MDR, and ISO 13485 requirements, including 510(k) and De Novo submission support for software-driven medical devices. The company's expertise spans design control, reliability analysis, and regulatory strategy for medical device manufacturers and service providers.

DTPM INC. is a laboratory solutions distributor and service provider serving physician offices, reference labs, recovery courts, and treatment centers across 47 US states since 1993. The company provides turnkey laboratory solutions including testing equipment, consumables, reagents, and comprehensive lab management services. DTPM offers an FDA EUA-authorized COVID-19 RT-PCR assay validated for detection of multiple SARS-CoV-2 variants including delta and omicron strains. The company distributes Solstice Advanced Materials (formerly Honeywell Research Chemicals) products including DNA/RNA purification kits applicable to bacterial, viral, and fungal samples, as well as complex matrices such as buccal swabs, saliva, respiratory samples, and blood. DTPM FreeWipes are single-ply, lint-free laboratory wipes available in bulk quantities. The company operates an online store offering analyzer consumables, collection supplies, laboratory chemicals, equipment, and general supplies from multiple manufacturers. DTPM has developed over 150 molecular assays and employs staff with 26+ years of laboratory setup experience and 30+ years of research expertise. Services include total program management for labs, dedicated technical support, point-of-care training and certification, and laboratory information systems (LIS) with online data and results management capabilities. The company focuses on high-volume routine and specialty testing, drug testing coordination with recovery and treatment programs, and customized solutions for various laboratory settings.

Fieldtex Products Inc. is a Rochester, NY-based contract manufacturer and medical supplies distributor operating three integrated divisions since 1973. Fieldtex Cases provides domestic contract sewing services from prototype to production, leveraging 60+ in-house skilled sewing machine operators. e-First Aid Supplies stocks and distributes over 960 first aid and EMS products and offers custom medical supplies fulfillment services. OTC Benefit Solutions administers over-the-counter supplemental benefit programs for Medicare Advantage health plans, with 480,000+ benefit packages delivered. The company specializes in custom kitting, assembly, and fulfillment services tailored for telehealth providers, healthcare organizations, and wellness brands. Fieldtex emphasizes compliance, scalability, and cost-effective logistics. The company is a certified small business subcontractor (Berry Compliant) for U.S. government vendors. Services include medical fulfillment, custom assembly, and logistics support for healthcare and telehealth markets.

Randox Laboratories is a global leader in diagnostic solutions with over 40 years of expertise in clinical laboratory, molecular, and point-of-care diagnostics. The company manufactures a comprehensive portfolio including the RX Series clinical chemistry analyzers, Vivalytic molecular point-of-care systems, and Evidence Series immunoassay analyzers. Randox provides open-channel reagents covering more than 100 disease areas including autoimmune disorders, cancers, and emergency/critical care diagnostics. The company operates as the world's largest external quality assessment (EQA) provider through RIQAS and QCMD platforms, serving over 100,000 users across 145 countries. Core offerings include quality control solutions (Acusera brand), third-party diagnostic assays, molecular infectious disease controls, and QC data management software. Beyond laboratory equipment, Randox operates multiple specialized service divisions: Contract Manufacturing (OEM partnerships), CDx and Biopharma services (biomarker development), Genomics (end-to-end sequencing with in-house bioinformatics), Pathology Services (sample collection and advanced testing), Toxicology (forensic drug detection for 600+ substances), Workplace Drug and Alcohol Testing, Food Diagnostics (antimicrobial and toxin screening), and Randox Health (preventative healthcare and home testing kits). The company serves clinical laboratories, reference labs, pharmaceutical companies, food/beverage industry, workplace testing, and forensic applications globally.

QA/RA Consulting Group, Inc. is a medical device consulting firm founded in 2012, specializing in regulatory affairs, quality management, and product development services. The company delivers market access solutions to medical device manufacturers, combination device developers, IVD companies, and pharmaceutical firms—ranging from startups to Fortune 500 enterprises. QA/RA CG has supported over 225 clients with operations across 23 countries worldwide. Core service offerings include FDA regulatory compliance, US Initial Importer and Official Correspondent services, quality management system (QMS) development and implementation, and strategic commercialization consulting. The firm's team comprises experienced consultants with backgrounds in engineering, science, and regulatory affairs, including former industry quality and regulatory leaders with direct FDA interaction experience. Services span the full product lifecycle: design, development, manufacturing, marketing, and distribution of medical devices. QA/RA CG emphasizes customized, strategic solutions tailored to client-specific needs, combining efficiency with compliance across multiple regulatory jurisdictions and economic regions.

ML LifeSciences is a contract manufacturer specializing in custom sterile reagents and media for clinical, diagnostic, biotech, veterinary, and quality control laboratory applications. The company offers terminal sterilization, aseptic fills, universal transport media, and compounded reagents across traditional and emerging formulations. Manufacturing capabilities span the full product lifecycle: raw material sourcing, formulation, sterile manufacturing, and packaging in client-specified containers including syringes, transport vials, tubes, PVC and EVA solution bags, and polycarbonate bottles. The company serves clinicians, researchers, laboratory professionals, and diagnostic laboratories with custom solutions for QC, diagnostic, biotech, and veterinary applications. ML LifeSciences is ISO 9001 certified and maintains compliance with federal and state regulatory agencies, ensuring rigorous manufacturing standards and quality control. The company emphasizes on-time delivery, consistent product quality, and superior value for demanding and time-critical projects.

Rescue Trade OHG is a European ISO 13485-certified medical device manufacturer founded in 2004, specializing in disposable bedding, transfer sheets, and transport sheets for patient care. The company operates three primary product brands: Rescue Bedding® (disposable bedding sets for hygienic patient care), Rescue Transfer® (disposable transfer sheets for safe patient repositioning), and Rescue Carry® (disposable transport sheets for secure patient handling). FDA-registered and MDR-compliant, the company serves hospitals, nursing homes, emergency medical services, patient transport operations, airports, public institutions, military organizations, and disaster relief operations. Products are designed for short-term use and comply with applicable regulatory requirements across Europe (BfArM/Eudamed) and the United States. The company offers both standard quantities and large-scale orders, including a subscription-based virtual warehouse and logistics service ensuring reliable delivery. Quality management is certified by notified body DQS Med. All products undergo strict quality control manufacturing processes.

LYNX Medical is an ISO 13485-certified, FDA-registered contract manufacturer and sterilization service provider serving the medical device industry. The company operates facilities in Pennsylvania and New Jersey, offering three primary service lines: contract assembly and cleanroom packaging for early-stage and full-scale medical device production; ethylene oxide (ETO) sterilization processing compliant with ISO 11135; and sterilization validation support. LYNX Medical guarantees 24-hour ETO processing turnaround for devices packaged in-house and commits future sterilization capacity throughout a product's lifecycle. The company positions itself as a supply chain optimization partner, reducing lead times and eliminating logistics costs through integrated packaging and sterilization services. All operations meet regulatory requirements and industry standards for medical device manufacturing and processing.

AMPO USA is a Service Disabled Veteran Owned Small Business (SDVOSB) headquartered in Franklin, Tennessee, providing medical supplies, occupational uniforms and equipment, custom polymer films and liners, and logistics coordination services. The company manufactures 100% American-made products across multiple categories. Medical product lines include syringes, nitrile and surgical gloves, gowns, masks, hospital liners, and disinfectants/sanitizers. The company operates 16 mono-layer extruders for custom polyethylene bag and film production in multiple thicknesses, widths, and density resins. AMPO USA specializes in supply chain solutions for medical device manufacturing, retail, semiconductors, aerospace, and e-commerce sectors. The company serves military, government, and commercial customers throughout the United States. Founded and operated by a combat veteran and former U.S. Army Officer, AMPO USA maintains strong community commitment through its 1:100 Program, donating 1% of corporate profits and 100% of online store profits to veteran support organizations.

Biotech Research Group (BRG) is a full-service regulatory and product development consulting firm headquartered in Tampa, Florida. BRG specializes in expedited commercialization pathways for pharmaceutical, biologic, and medical device companies navigating FDA and global regulatory requirements. The firm maintains a global network of expert consultants across 60+ countries with specialized expertise in toxicology, pharmacokinetics, statistics, epidemiology, and pharmacovigilance. BRG's core services span biologics (BLA, tissue registrations, vaccines, gene therapy), medical devices (510(k), PMA, PMN applications, implants, surgical devices), pharmaceutical drugs (NDA, ANDA, IND, OTC), quality assurance (ISO clean room operations, audits, SOP implementation, FDA adverse event reporting), and specialty services including emergency use authorizations, expert witness testimony, and literature reviews. The firm emphasizes FDA compliance leadership, clinical research design, and quality management as keys to regulatory success, offering cost- and time-effective tailored product development plans.

Spok, Inc. is a healthcare communications software company serving 2,200+ hospitals globally. The company delivers clinical information to care teams through secure, HIPAA- and HITECH-compliant platforms designed to improve patient outcomes and care delivery workflows. Spok's unified platform, Spok Care Connect, integrates multiple communication channels including secure messaging, on-call scheduling, contact center solutions, facility alerting, clinical care notifications, paging services, and clinical test result management. The platform automates critical clinical workflows such as patient alerts, clinician consults, code calls, and test result notifications. Core modules include enterprise directory management with role-based access, EHR-driven clinical alerting, rapid code and response activation, acuity-based routing and escalation, and IVR automation for routine requests. The solution is device-agnostic, enabling communication across smartphones, tablets, and traditional devices. Spok also serves government and emergency services with enhanced E9-1-1 accuracy and integrated PSAP tools. Customers report 70+ million messages sent monthly through Spok solutions. The company has 30+ years of experience in healthcare communications and maintains partnerships with leading healthcare systems including VCU Health and Mercy Iowa City.

Truer Medical is a U.S.-based medical device manufacturer specializing in precision-engineered disposables and accessories for anesthesia and perioperative care. Since 2007, the company has supplied hospitals, clinics, and surgery centers with temperature management disposables, airway management solutions (intubation stylets, esophageal stethoscopes), gas sampling lines, and tubing circuits. All products are ISO 13485 certified and CE marked. Truer Medical offers in-house contract manufacturing, design and product development, and FDA regulatory expertise. The company provides competitive pricing, same-day shipping, flexible MOQs, and private labeling options. Recently expanded into the veterinary medical device market.

HiArc is a medical device engineering and manufacturing company specializing in design, engineering, and manufacturing services for diagnostics and life sciences companies. Founded in 1980 and based in Merrimack, New Hampshire, the company employs 200–500 people and operates as a strategic partner across the full product lifecycle—from concept development and engineering design through manufacturing and ongoing support. HiArc brings deep expertise in laboratory automation, robotics, precision engineering, microfluidics, thermal control, optics, and motion control. The company serves startups and global original equipment manufacturers in the diagnostics, biotech, and medtech sectors, with over 40 years of partnership experience. HiArc emphasizes collaborative, quality-driven processes that align with client goals and deliver regulatory-compliant, real-world-ready solutions.

Katecho, LLC is a contract medical manufacturing company headquartered in Des Moines, Iowa. The company specializes in end-to-end medical device and pharmaceutical manufacturing services, including product design, prototyping, process development, and logistics solutions. Core capabilities span product and process design, multiple printing technologies (flexographic, rotary screen, and bed screen printing), and comprehensive manufacturing services including engineering, converting, and assembly. Katecho is recognized as a world leader in hydrogel design and manufacturing for medical applications and operates Surmasis, a contract pharmaceutical manufacturing division. The company serves as a full-service partner for medical device manufacturers and pharmaceutical companies, offering integrated solutions from concept through commercialization. Manufacturing capabilities support both discrete medical devices and continuous-process pharmaceuticals. Katecho provides logistics and supply chain management as an extension of customer operations. The company operates from an established facility in Des Moines and maintains standard contract manufacturer quality and regulatory compliance standards typical of medical device manufacturers serving FDA-regulated markets.

Medical Device Post-Production Services, Inc. (MDPPS) is a regulatory and compliance consulting firm specializing in enabling foreign medical device manufacturers to commercialize products in the United States. Core services include acting as a U.S. Agent for device registration and sales, Initial Importer representation for FDA compliance, and strategic consulting on Quality Management Systems (QMS), device design and development, manufacturing strategy, and regulatory/standards compliance. MDPPS guides clients through FDA establishment registration, medical device reporting requirements, and the full import/regulatory pathway to market entry. The firm serves as a bridge between international device manufacturers and U.S. regulatory frameworks, handling documentation, customs coordination, and compliance validation to streamline device commercialization.

Almitas Group International is a 100% Australian-owned medical and industrial procurement, manufacturing, and logistics specialist with offices across four countries. The company provides tailored solutions to top-tier medical, pharmaceutical, government, laboratory, and mining entities globally. Specialising in medical consumables, protective attire (examination gloves, surgical masks, isolation gowns, protective coveralls), and hypodermic syringes, Almitas combines in-house quality assurance, independent testing expertise, and 15+ years of manufacturing and procurement experience. The firm operates independent quality assurance systems, maintains international freight and logistics capabilities, and holds certifications including TGA, FDA, CE, ISO, NIOSH, and BSI. Services encompass medical supplies distribution, custom manufacturing, high-level procurement, logistics and warehousing, and consulting support.

Tensentric is an ISO 13485:2016 certified engineering and manufacturing firm specializing in design, development, prototyping, and volume production of medical devices, in-vitro diagnostics (IVD), and life sciences systems. Founded in 2009 and headquartered in Boulder, Colorado, the company employs 83–96 engineers and scientists, many with over 20 years of experience across electromechanical systems, microfluidics, bioprocessing, and human factors optimization. With over 300 completed development projects and 75+ patents, Tensentric delivers turn-key system design from concept through volume manufacturing. Core competencies include custom-engineered instruments and consumables, point-of-care diagnostic platforms, cell and gene therapy bioprocessing equipment, and complex integrated systems for sample handling, biochemical analysis, and detection. Services encompass design and development, human factors and use-safety engineering, new product introduction (NPI), and dedicated manufacturing. Clients include Medtronic, BD, Philips, Johnson & Johnson, Stryker, and other major medtech OEMs. In 2022, the firm received strategic investment from GenNx360 Capital Partners to expand manufacturing and business development capabilities.

ASP Global is a leader in direct healthcare sourcing, product development, and medical consumables distribution, headquartered in Atlanta, Georgia. Established in 2003, the company operates a global network of over 100 production facilities across 10 countries and maintains management offices in the U.S. and Asia-Pacific. ASP Global specializes in a 'Product Plus Service' business model that optimizes healthcare supply chains for major integrated delivery networks, health systems, hospitals, and distributors. The company offers more than 3,400 unique medical consumables spanning admissions supplies, surgical products, and wound prevention solutions. Key branded product lines include PRIMO (injury prevention and patient experience products), RAM Scientific (blood collection systems), MediCore, and Shumsky Therapeutic Pillows. ASP Global provides comprehensive strategic sourcing, custom product development, private label manufacturing, product customization, and supply chain optimization services, focusing on cost management, quality assurance, and supply chain resiliency for major U.S. healthcare providers.

Apical Instruments is a medical device design, engineering, and manufacturing company specializing in electrosurgical generators and related medical RF systems. Based in Redwood City, California, Apical provides end-to-end product development services including proof-of-concept evaluation, prototype development, design validation, and full-scale manufacturing. The company maintains ISO 13485 Design Control processes and FDA Quality System compliance, with expertise in regulatory submissions (FDA 510(k), European notified body audits) and medical device patents. Apical serves biotechnology and medical device firms seeking to streamline development timelines while ensuring quality and regulatory compliance from inception through production and ongoing support.

Mentor Media Supply Chain Solutions, a subsidiary of the Elanders Group, is a global provider of supply chain management services established in 1984. Headquartered in Singapore with facilities in Warsaw, Indiana, the company specializes in customized, technology-driven solutions for medical devices, consumer electronics, communications, computing, software, and retail industries. Mentor Media operates ISO and GDPMDS-certified state-of-the-art facilities providing validated sterile medical packaging with 10-year shelf life, cleanroom operations, and comprehensive end-to-end supply chain capabilities. The company offers global warehouse management, healthcare service solutions, print and packaging, e-service/IoT integration, value-added services, and custom configuration and assembly. With a network spanning America, Europe, and Asia-Pacific, Mentor Media leverages proprietary software for order management and real-time analytics to enhance operational efficiency, reduce costs, and accelerate time-to-market for healthcare and industrial products while maintaining sustainability and business continuity.

Eagle Medical, Inc. is a medical device packaging and sterilization service provider specializing in blister tray and pouch packaging. The company operates a 20,000 square-foot ISO 13485:2016-certified facility in Paso Robles, California, featuring over 2,500 square feet of ISO 14644-1 Class 7 cleanrooms. Services include contract sterilization (hydrogen peroxide gas plasma, E-beam, ethylene oxide, and gamma beam irradiation), contract assembly and packaging, package design, tooling design and fabrication, and comprehensive validation support (sterilization, packaging, cleaning, and process validation). The company also provides regulatory consulting for 510(k) and PMA submissions, incoming inspection, device master records, batch records, and protocol development. Eagle Medical serves OEM medical device manufacturers with expertise in GMP compliance, vendor audits, and inventory control systems.

Coastline International is an FDA-registered, ISO 13485 & ISO 9001 certified contract manufacturer specializing in nearshore medical device and electronics manufacturing. Headquartered in San Diego, California, with manufacturing facilities strategically located in Tijuana, Mexico, Coastline has served OEM clients for over 40 years. The company operates 65,000+ square feet of manufacturing space, including five ISO Class certified cleanrooms, and employs 200+ skilled personnel. Coastline provides comprehensive contract manufacturing solutions for Class I, II, and III medical devices, disposables, surgical instruments, electronic assemblies, and custom components. Services include cleanroom assembly and packaging, finished device assembly, soldering (IPC standard), custom battery pack assembly, sterile-barrier packaging, RF welding, ultrasonic welding, sterilization management, metrology, and import-export expertise. The company leverages nearshore advantages including 30%+ cost reduction versus domestic or in-house manufacturing, reduced transit times, proximity to U.S. ports of entry, and USMCA trade benefits. Coastline also offers shelter services, program management, materials procurement and logistics, quality assurance testing, and first article inspection.

Boulder iQ is a specialized life sciences consulting and contract services firm headquartered in Boulder, Colorado, providing comprehensive support to medical device, diagnostic, and combination product companies. The firm operates as a family of integrated companies: Boulder iQ (engineering, design, development, and manufacturing); Boulder Sterilization (contract sterilization services); Boulder Regulatory Affairs and Quality Assurance (regulatory and QA support); and Boulder BioLabs (contract testing and validation). With over 40 years of collective expertise and ISO 13485:2016 certification, Boulder iQ serves clients across 33 U.S. states and 6 countries. The company specializes in concept-to-commercialization support, including product design, prototyping, manufacturing, quality systems, regulatory pathway navigation, and sterilization validation. Boulder Sterilization is recognized as the sole U.S. contractor offering both ethylene oxide and chlorine dioxide sterilization, and the world's largest contract chlorine dioxide sterilizer.

Healthcare Tech Solutions is a specialized medical imaging IT consulting and services firm serving healthcare organizations nationwide. The company provides comprehensive DICOM data migration services, PACS administration and support, VNA (Vendor Neutral Archive) consulting, and enterprise imaging management. Core service offerings include self-managed and full-service DICOM migrations, SCO-to-BTO and CTO-to-BTO breast imaging conversions, PACS system implementation advisory, and staffing solutions with vetted medical imaging professionals. The company also supplies diagnostic displays/monitors, media systems, and medical imaging hardware. Founded by former PACS administrators, Healthcare Tech Solutions addresses challenges in data integration during hospital mergers and acquisitions, legacy system conversions, and imaging workflow optimization. The firm offers strategic guidance, implementation project management, infrastructure design, and ongoing technical support to streamline operations and enhance patient care while reducing costs and operational disruptions.

Rexmed Health is a medical device original equipment manufacturer (OEM) and contract manufacturer based in El Paso, Texas, with a manufacturing plant in Ciudad Juarez, Mexico. The company specializes in designing, engineering, and manufacturing medical devices for parenteral delivery, infusion therapy, and specialty applications. With over 20 years of experience, Rexmed manufactures products serving ophthalmic surgery, urology, parenteral nutrition, IV therapy, cardiology, airway management, and pain management sectors. Core manufacturing capabilities include fluid delivery sets, infusion pump systems, parenteral bags and configurations, and surgical dispensing coils, produced in certified clean rooms (Class 8 environment). The company holds FDA approval, COFEPRIS (Mexican regulatory) certification, CT-PAT customs certification, and operates under cGMP compliance. Rexmed provides integrated services including process validation (IQ/OQ/PQ), sterilization management, logistics and warehousing, testing services, and master validation planning. The company works with major national and multinational pharmaceutical organizations and emphasizes customized solutions, hand assembly capabilities, special testing, and small-lot production flexibility. Rexmed maintains lean enterprise methodology with six sigma practices and is recognized as a socially responsible company (ESR) by the Mexican Center for Philanthropy. Distribution and logistics partnerships include Silan Medexo (import/export), Doniphan Logistics (distribution center), and PJ Technologies (infusion pump system distribution).

Stevens-Moon & Associates is a Midwest medical equipment distributor and manufacturer founded in 1994, headquartered in Williamston, Michigan, serving Michigan, Ohio, Indiana, and Kentucky. The company distributes, sells, represents, installs, and repairs medical equipment and supplies from leading manufacturers. Stevens-Moon specializes in manufacturing and distributing radiation protection products including lead aprons, thyroid collars, and custom radiation protective accessories. The company also stocks medical storage solutions, surgical instruments, and patient transfer products. With over 30 employees and a family-owned structure, Stevens-Moon is known for knowledgeable service technicians and customer-focused sales representatives who provide installation and repair services to healthcare facilities across the region.

Catalent is a global Contract Development and Manufacturing Organization (CDMO) serving pharmaceutical, biotech, consumer health, and self-care companies. Founded in 2007 and headquartered in Tampa, Florida, the company operates over 50 sites worldwide with approximately 8,500 employees. Catalent specializes in end-to-end drug development, manufacturing, and supply chain services, leveraging advanced technologies including softgel encapsulation, Zydis Ultra oral fast-dissolve systems, and proprietary molecular optimization platforms. Core service areas include oral dose forms, biologics development and manufacturing (drug substance and drug product), cell and gene therapy, specialty dose delivery (inhalation, nasal, pulmonary systems), clinical supply chain management, and self-care product development. The company provides comprehensive analytical chemistry, formulation development, bioavailability studies, regulatory support, clinical packaging, comparator sourcing, and distribution logistics. Catalent has a proven track record supporting FDA approvals and commercial product launches across multiple therapeutic areas.

Custom Manufacturing Incorporated is a non-automated contract manufacturer specializing in single-use and disposable medical devices, electrosurgical devices, and cardiac insulation pads classified as Class I medical devices. Founded in 1996, the company provides comprehensive manufacturing, assembly, packaging, and labeling services for medical device manufacturers and OEMs. Manufacturing capabilities encompass simple to complex assembly operations, including kit assembly, with flexibility to accommodate client specifications. Packaging services include pneumatic, heat, impulse, and other sealing methods ensuring packaging integrity and seal strength. The company offers detailed labeling capabilities from basic information labels to Microscan LVS barcode labels. The facility includes a state-of-the-art ISO Class 7 controlled clean-room environment certified per ISO Standard 14644-1:2015, enabling production of sterile and contamination-controlled medical devices. The company also manufactures non-medical devices. Operating from Elbert, Colorado, Custom Manufacturing serves medical device manufacturers requiring domestic contract manufacturing with quality assurance and regulatory compliance. The facility's large production area supports simultaneous manufacturing, cleaning, packaging, labeling, and assembly of multiple product lines.

FuzeRx (operated by Truepill) is a URAC-accredited pharmacy and telehealth platform specializing in end-to-end digital pharmacy solutions for Life Sciences companies, payers, healthcare providers, and consumer health brands. The platform offers configurable APIs and white-label technology designed to streamline prescription fulfillment, patient management, and clinical data handling. FuzeRx provides three primary service models: Virtual Pharmacy (all-in-one platform combining hub and dispensing), Hub+ (automation-driven pharmacy hub with improved patient access and adherence), and Dispensing (specialty and brand medication fulfillment with nationwide 50-state shipping and same-day courier options). The platform processes over 25M prescriptions for 6M+ patients with 41% processed within 2 minutes. Deep therapeutic expertise spans women's health, endocrinology, and immunology. Features include configurable patient safety APIs for drug utilization reviews, customizable health questionnaires, insurance and FSA/HSA payment processing, custom branded packaging, and comprehensive data dashboards. URAC-accreditation ensures compliance with pharmacy and specialty pharmacy standards.

RAF Solutions USA is a regulatory and logistics services provider specializing in enabling foreign medical device and IVD manufacturers to enter and scale within the North American market. The company delivers comprehensive solutions spanning US regulatory affairs (FDA registration and compliance), customs clearance, import/export logistics, warehousing, inventory management, and order fulfillment. With expertise in MDR compliance, tariff optimization, and market-specific requirements, RAF acts as a US agent and initial importer for international manufacturers across multiple healthcare sectors. The firm combines regulatory intelligence, supply-chain logistics, and business advisory to reduce market entry costs and risks for client manufacturers.

Tegra Medical is a global contract manufacturer specializing in end-to-end production of medical devices. Headquartered in Franklin, Massachusetts, with manufacturing facilities across the United States, Costa Rica, Switzerland, and Asia, the company employs over 1,000 people. Tegra Medical delivers comprehensive manufacturing solutions including design, prototyping, precision production, assembly, packaging, and sterilization for complex metal and plastic components. The company serves multiple therapeutic areas including oncology, orthopedics, cardiology, minimally invasive surgery, ophthalmic, women's health, drug delivery, and robotic-assisted surgery applications. Advanced manufacturing capabilities include Swiss machining, multi-axis milling, injection molding, wire grinding, and precision finishing. Tegra Medical maintains ISO 13485 certification and FDA registration, supported by rigorous quality management systems. The company also operates Quick Wire & Tubing, an e-commerce platform offering in-stock and custom wire, tubing, and secondary processing services for medical device development and prototyping.

MAK and Associates is a regulatory compliance and quality consulting firm specializing in medical device regulatory support. Led by Steve Krueger, a computer engineer and Six Sigma Black Belt with 20+ years of medical device industry experience, the firm provides expert guidance in FDA compliance, verification and validation, quality systems development, post-market surveillance, adverse event reporting, and regulatory submissions. Services include US FDA Agent representation for international medical device companies, compliance monitoring programs, and risk-based testing strategies. The firm serves medical device startups and established manufacturers navigating FDA, MDR, and ISO requirements to accelerate market entry and ensure regulatory compliance.

Steritec Services LLC is a contract sterilization and biological testing provider specializing in medical device processing. The company operates a 54,000 square foot facility in Athens, Texas, equipped with ethylene oxide (EO) and steam sterilization chambers, along with comprehensive chemical and biological testing laboratories. Core services include 100% ethylene oxide sterilization, steam sterilization, sterility testing, LAL endotoxin analysis, EO residuals testing, and bioburden assessment. The company serves medical device manufacturers requiring validated sterilization processes and regulatory-compliant testing support, including ISO 11135 process validation, biological indicator testing, and process validation documentation. Steritec also provides professional consulting guidance for regulatory compliance and sterilization program development.

Dawa Medical is a B2B medical device consulting and logistics company specializing in market entry, regulatory compliance, and distribution support for international medical device manufacturers targeting the US market. The company provides initial importer services, FDA agent representation, warehousing, domestic shipping, distribution network development, invoicing support, and Certificate to Foreign Government (CFG) acquisition for markets in Asia, the Middle East, and Latin America. With expertise across interventional radiology, interventional cardiology, vascular surgery, orthopedics, spine, surgical oncology, dental, and wound care devices, Dawa Medical assists manufacturers in navigating FDA regulations, establishing qualified distributor relationships, and scaling product distribution efficiently. The company combines consulting, regulatory guidance, and logistics infrastructure to streamline the commercialization process for medical device companies.

Novex Innovations is a contract development and manufacturing organization (CDMO) specializing in the design, development, and commercialization of biologics, pharmaceuticals, medical devices, and bioengineered tissue. Operating a 36,000 square-foot cGMP-compliant facility with Class 100 and Class 1,000 cleanroom spaces, the company provides comprehensive services spanning product and process development, clinical and commercial manufacturing, regulatory support, and distribution. Capabilities include biological formulations, clinical formulation, tissue processing, active pharmaceutical development, diagnostic materials manufacturing, and inventory management. ISO 13485 certified and FDA-registered, Novex supports clients from proof-of-concept through all phases of clinical trials to commercial scale-up and market distribution, serving both startups and multinational organizations across national and international markets.

Grifols is a leading global biopharmaceutical and healthcare company founded in 1909, headquartered in Barcelona with significant US operations. The company operates across four primary business divisions: Biopharma (plasma-derived medicines and biopharmaceuticals for immunology, hepatology, intensive care, pulmonology, hematology, neurology, and infectious diseases), Diagnostic (blood screening and transfusion medicine diagnostics), Bio Supplies (plasma collection and processing supplies), and Healthcare Solutions for Hospitals (hospital equipment and consumables). Grifols manufactures and distributes innovative plasma-derived therapeutic products, clinical laboratory equipment and reagents, diagnostic assays, and healthcare infrastructure solutions for hospital and transfusion medicine settings. The company operates a global plasma donation center network and engages in research and development across multiple therapeutic areas, including immunological disorders, rare diseases, and infectious disease screening. Grifols maintains regulatory compliance with FDA approvals (evidenced by recent malaria blood screening assay approval), ISO standards, and international quality certifications. The company serves healthcare systems, blood banks, hospitals, clinical laboratories, and patients globally, with established operations and partnerships across the Americas, Europe, and Asia-Pacific regions.

Molded Products is an FDA-registered medical device manufacturer specializing in injection molded dialysis products and supplies since 1986. The company manufactures over 200 dialysis-specific products including transducer protectors, dialyzer holders, fistula clamps, and related components. In addition to dialysis equipment, Molded Products serves veterinary, laboratory, and apheresis industries. The firm offers end-to-end contract manufacturing services including custom mold design, precision machining, and custom packaging. Materials expertise spans plastics and metals. While the company also serves non-medical sectors (semiconductor, agricultural, commercial refrigeration), its core B2B business focuses on supplying FDA-compliant medical devices and components to healthcare providers and equipment manufacturers.

WestBridge Vocational is an FDA-registered social enterprise manufacturing facility specializing in disposable medical devices. The company produces surgical drapes and wraps for leading medical suppliers and distributors. Additionally, WestBridge offers custom medical sewing services, including catheter covers, shoulder stabilizers, medical equipment coverings, and neonatal medical products. The facility operates as a controlled-environment manufacturing center serving domestic and international markets. Beyond manufacturing, WestBridge provides vocational rehabilitation program services and employment training for adults and youth with barriers to employment, operating under contract with the North Carolina Division of Vocational Rehabilitation. The company supports over 100 participants in job skills development and employment marketability enhancement. As a mission-driven manufacturer, WestBridge combines quality-driven production with workforce development, positioning itself as a contract manufacturing partner for B2B medical supply companies seeking domestic USA manufacturing capacity with trained workforce support.

Revelation Medical Devices (RMD) is an ISO 13485:2016 certified contract manufacturer specializing in precision medical device design, prototyping, and production for the orthopedic and spinal markets. With over 45 years of manufacturing heritage (formerly Stamets Tool & Engineering), RMD operates a 14,000 sq ft facility in Auburn, Indiana—strategically located 45 minutes from Warsaw, the orthopedic capital. The company serves medical device OEMs, startups, and established innovators with full-cycle capabilities including 3/4/5-axis CNC milling, live-tool turning, laser/TIG welding, laser etching, passivation, polishing, poly manufacturing, and non-sterile packaging/labeling. FDA-registered (No. 1836116) and committed to quality, on-time delivery, and partnership-driven development.

Biomerics is a leading vertically integrated contract development and manufacturing organization (CDMO) specializing in interventional medical devices and components. Established in 1994 and headquartered in Salt Lake City, Utah, the company operates 12 facilities globally across the United States, Ireland, Costa Rica, and the Dominican Republic, employing over 3,200 professionals. The company ranks among the Top 10 interventional CDMOs worldwide and serves 20 of the top 35 medical device OEMs. Biomerics provides end-to-end manufacturing capabilities including design engineering, materials compounding, complex extrusion, micromachining, micro metals processing, and finished device assembly. Core competencies span structural heart, electrophysiology, robotic surgery, endoscopy, and image-guided intervention platforms. The company offers specialized services including polymer and metal fabrication, device packaging, sterilization, and technology transfer. All operations maintain ISO 13485:2016 certification and FDA compliance, with dedicated Centers of Excellence in advanced materials, complex extrusion, and micromachining to support rapid innovation and market delivery.

Knipper Health is a comprehensive pharmaceutical and healthcare logistics provider established in 1986, serving the pharmaceutical, biotechnology, and medical device industries. Operating through three integrated divisions—Marketing and Sample Management, 3PL Logistics, and Custom Pharmacy Solutions—the company manages end-to-end supply chain and patient access solutions. Knipper Marketing and Sample Management supports over 25,000 sales representatives with sample distribution, processing millions of shipments annually with 99.9984% accuracy. Knipper3PL provides third-party logistics with 54,158 sq. ft. of refrigerated warehouse space and 30,828 sq. ft. of DEA-controlled substance storage, ensuring product availability at points of care. KnippeRx Custom Pharmacy Solutions offers white-label specialty pharmacy services, patient assistance programs, and personalized patient access support. The company serves 89% of top pharmaceutical companies and provides DSCSA serialization, compliance support, and patient advocacy services across the entire product lifecycle.

Ranfac Corp. is an ISO 13485:2016-certified Contract Development and Manufacturing Organization (CDMO), Original Equipment Manufacturer (OEM), and Contract Manufacturing Organization (CMO) specializing in custom Class I and Class II single-use hypodermic-based medical devices. Founded in 1888 and based in Avon, Massachusetts, Ranfac operates a vertically integrated 40,000 sq ft facility that manages all production stages in-house: metal machining (12 specialized processes including CNC, laser welding, electropolishing), polymer injection and insert molding (Class 8 cleanroom), cleaning and passivation, cleanroom assembly (Class 7 ISO), and EO sterilization via exclusive STERIS partnership. The company serves minimally invasive surgery access devices, biopsy and aspiration systems, orthobiologics delivery cannulas, interventional radiology components, hematology devices, and general surgery instruments. Ranfac supports low minimum order quantities and scales from prototype to 500K+ units annually. MDSAP, EU MDR, and FDA registered, enabling simultaneous access to seven export markets.

RevMed (operating as revmedconnect.com) is a B2B healthcare marketplace platform that connects hospitals and medical facilities directly to buy, sell, and trade medical equipment and supplies. The platform enables healthcare facilities to purchase surplus inventory from peer institutions at competitive pricing while allowing sellers to monetize excess equipment and consumables. RevMed offers a transparent, peer-to-peer model with fair market value pricing and low transaction fees. The marketplace catalogs a broad range of surgical instruments (laparoscopic sealers/dividers, linear cutters, hemostats), imaging equipment (bone densitometers, arthroscopy systems), emergency/critical care devices (defibrillators, sequential compression systems), and disposable surgical supplies from manufacturers including Covidien, Ethicon, Stryker, and Applied Medical. The platform includes a Chrome extension for price comparison while browsing and features product expiration tracking and inventory management tools to optimize healthcare supply chain efficiency.

Restore Robotics specializes in the remanufacturing and recycling of da Vinci Xi® robotic surgical instruments. Based in Panama City Beach, Florida, with a state-of-the-art remanufacturing facility in Henderson, Nevada, the company is the only organization with FDA 510(k) clearance for remanufacturing da Vinci Xi® robotic instruments. The company operates national sales and service centers providing medical device sales, instrument remanufacturing, and recycling of expired robotic instruments. Restore Robotics extends the lifecycle of surgical robotics equipment while supporting sustainability and cost-efficiency in surgical robotics procurement for hospitals and surgical centers.

STERIS Applied Sterilization Technologies is a contract sterilization and laboratory testing service provider serving medical device and pharmaceutical manufacturers globally. The company operates over 60 facilities worldwide offering a technology-neutral sterilization portfolio including gamma radiation, X-ray, electron beam, ethylene oxide (EO), hydrogen peroxide gas plasma (VHP), and steam sterilization. Core service offerings include contract sterilization with microbial reduction capabilities, laboratory testing and validation services (microbiological, analytical, product and package testing), integrated sterilization equipment and control systems with accelerators and conveyors, radiation dosimetry services using red perspex and alanine pellet dosimeters, and technical support through TechTeam professionals. The company provides real-time supply chain visibility through its Sterilink® online interactive service platform. Facilities are globally distributed across multiple regions with capabilities in X-ray, electron beam, gamma, ethylene oxide, VHP, and steam technologies, supplemented by laboratory testing and equipment & technology services. STERIS AST serves manufacturers requiring regulatory-compliant sterilization validation and processing for medical devices and pharmaceuticals, offering comprehensive technical guidance through complex sterilization and testing processes.

Carwild Corporation is a contract medical device manufacturer operating facilities in New London, Connecticut, and San Pedro de Macorís, Dominican Republic, in partnership with Medsorb Dominicana, S.A. The company specializes in absorbent medical technologies and custom converting services for the medical device industry. Carwild manufactures products using polyvinyl acetate (PVA) and hydrophilic urethane (PU) foam, specialty medical-grade threads, and North American-sourced cotton, rayon, and composite materials. Converting capabilities include injection molding, die-cutting, sonic welding, sewing, assembly, and sterile packaging. The company holds ISO 13485 certification and U.S. FDA registration, ensuring compliance with medical device manufacturing standards. Carwild serves diverse medical markets including dental, ophthalmic, ENT, orthopedic, neurological, endovascular, and wound care applications. The company operates a ship-to-stock program and distributes to over 45 countries worldwide. Founded in 1978 by Joel Wildstein, Carwild is family-owned and currently led by second-generation president David Wildstein. With over 40 years of medical industry experience, the company provides scalable manufacturing solutions ranging from small-batch custom projects to large-scale production. Manufacturing includes absorbent component fabrication, precision converting, and complete assembly with sterile packaging capabilities.

IRP Medical is a contract manufacturer of critical-to-function elastomeric components for the medical device industry, established in 1980. The company specializes in liquid injection molding (LIM), liquid silicone rubber (LSR), and compression molding of highly precise elastomer and silicone components. With ISO 13485:2016 certification and FDA registration, IRP Medical provides turn-key manufacturing solutions spanning from prototype development through mass production scaling to millions of parts. Core capabilities include complex liquid silicone and rubber molded components with tight tolerances, custom rubber formulations, thermoplastic molding for LSR overmolding, flashless transfer tooling, cold runner and hot runner tooling, and gum injection molding. The company operates a controlled manufacturing environment with state-of-the-art LIM machinery and maintains 24/7 production capacity for time-sensitive and large-scale projects. IRP Medical serves medical device OEMs requiring high-volume, precision elastomeric components for critical applications. The company emphasizes design for manufacturability, experienced engineering and tooling support, and reliable scalability from prototype to millions of parts while meeting stringent quality and volume targets.

Stericycle is a global healthcare compliance and waste management company specializing in regulated medical waste disposal, sharps management, and pharmaceutical waste handling. With 30+ years of experience and 15,000 team members worldwide, the company provides end-to-end management and disposal of healthcare regulated waste streams serving physician offices, dental clinics, hospitals, and health systems. Core service offerings include biohazardous medical waste disposal (compliant transportation, treatment, and disposal), sharps waste management and disposal (reusable and disposable container options targeting needlestick injury reduction), pharmaceutical waste management and disposal (compliance-based solutions), and OSHA and HIPAA compliance solutions with training and online resources. The company operates with 97% on-time service performance. Stericycle has treated 1.3 billion pounds of medical waste, diverted 101 million pounds of plastic from landfills through reusable containers, incinerated 55 million pounds of pharmaceutical waste, and recycled 906 million pounds of paper. The organization is committed to workplace safety and infection control across all healthcare settings and regulatory compliance, supporting facilities in managing complex regulatory landscapes through in-house compliance education specialists.

BMP Medical is a contract medical plastics manufacturer specializing in custom injection molding and injection blow molding for OEM medical device companies. Established over 45 years ago, the company operates an 80,000 sq. ft. manufacturing facility in Sterling, Massachusetts, featuring 24 molding machines (including 3 injection blow molding units), an 8,000 sq. ft. ISO Class 8 cleanroom, and 30,000 sq. ft. of warehouse space. BMP Medical offers comprehensive services including design and development, expert engineering consultation, precision manufacturing, cleanroom assembly, sterile packaging, process validation (IQ/OQ/PQ), and in vitro diagnostic (IVD) component manufacturing. The company is ISO 13485:2016 certified, FDA registered, and cGMP compliant. Core capabilities include plastic injection molding, injection blow molding, cleanroom Class 7 and Class 8 manufacturing, custom assembly, and private-label packaging solutions. BMP Medical serves pharmaceutical packaging, medical device component, and diagnostic component markets, with an average OEM partnership duration of 10 years. The company emphasizes collaborative, long-term partnerships and flexibility in scaling production for regulated medical devices and diagnostic equipment.

ATZ Manufacturing is a family-owned medical device and specialty equipment manufacturer based in Marshall, Minnesota, founded in 2009. The company specializes in designing and manufacturing electric tracked drive systems for mobility and utility applications. Their core product line includes Trackchair®, an all-terrain wheelchair with three FDA-cleared models among ten total offerings, designed to enable individuals with mobility impairments to access outdoor environments. The Trackporter® is a robust 24-volt electric tracked drive system for hauling and industrial applications, offered in three models: Original, Coyote, and Apprentice. Trackbot® is a remote-controlled, modular electric track drive platform engineered for customizable deployment across diverse industries and specialized tasks. Beyond product manufacturing, ATZ operates comprehensive contract manufacturing services including precision laser cutting, TIG/MIG welding, CNC machining, tube bending, powder coating, and rapid prototyping. The company serves healthcare, recreational, industrial, and commercial markets. All Trackchair® models are engineered for rugged all-terrain performance and FDA regulatory compliance. ATZ Manufacturing evolved from its predecessor, Action Manufacturing, maintaining a commitment to innovative custom solutions and American manufacturing.

Strategic Lab Partners (SLP) is a US-based, FDA-registered kitting and logistics provider headquartered in Memphis, Tennessee. The company designs, manufactures, and distributes custom healthcare kits for clinical trials, decentralized research programs, precision medicine initiatives, and direct-to-consumer health programs. SLP specializes in FDA Class I & II specimen collection and transport devices, including saliva sampling kits, DNA/RNA collection systems, and multi-analyte panel containers. The company has delivered over 55 million kits to more than 400 clients worldwide. SLP's core offering is Universal Kitting—a fully integrated ecosystem combining protocol-to-kit translation, FDA-registered production, serialized kit assembly, private labeling, nationwide 3PL fulfillment, climate-controlled warehousing, and real-time chain-of-custody tracking via the proprietary SLP CONNECT™ digital platform. Services include supply chain analysis, cost savings modeling, bulk healthcare supplies sourcing, and lab partner introduction. SLP CONNECT™ provides scan-based chain-of-custody from kit assembly through final dataset delivery, inventory management, shipment visibility, and exception alerting. The company emphasizes pre-analytical integrity, reduced specimen redraws, improved clinic and OR efficiency, and regulatory compliance (FDA, IVDR). Target markets include women's health programs, biotech firms, clinical research organizations, government services, retail health providers, and multi-omics research centers. SLP operates a centralized production hub in Tennessee with controlled nationwide distribution and secure warehousing infrastructure.

Team Technologies, Inc. (rebranding as Cordica Medical as of January 2026) is a comprehensive medical device manufacturer and contract development and manufacturing organization (CDMO) headquartered in Knoxville, Tennessee. The company operates across multiple therapeutic and product categories, serving the diagnostic, surgical, and therapeutic markets with proprietary and contract manufacturing capabilities. Core product lines include: interventional cardiology and neurovascular catheter-based devices; in vitro diagnostic (IVD) testing and lateral flow assays; wearable patient monitoring sensors; advanced wound care products; infection control and PPE solutions (including privacy curtains, disposable apparel, and accessory products); pharmaceutical delivery and dosing systems; patient handling and mobility solutions; and dental/oral care products (toothbrushes, prophy angles, prophylaxis supplies). Manufacturing capabilities span product design and rapid prototyping, catheter extrusion and assembly, precision medical tubing, injection and blow molding, textile converting, RF welding, advanced bristling and tufting, wet and dry chemistry formulation, sewing and textile processing, and value-added customization. The company operates under ISO 13485 and FDA-regulated guidelines. U.S.-based manufacturing and supply chain operations support medical device OEMs and diagnostic companies from concept through commercialization. Specialty product brands include ICP Medical (privacy curtains/PPE), Rapid Refresh, Protexer, Bootie Butler, Topi-CLICK dosing applicators, AllPro dental supplies, PDS and PHB toothbrushes, and Prophy Perfect prophy angles.

MedDev is a healthcare technology company specializing in regenerative medicine and advanced wound care solutions. The company distributes biologic skin substitutes based on amniotic membrane technology, designed to accelerate healing in chronic wounds, burn wounds, ophthalmic applications, and surgical procedures. Their product portfolio includes multiple branded skin substitute lines (XCell, XCellerate, Royal Wound, Precise, Royal Bio, BioLab, DermMax, and EnColl). Beyond product distribution, MedDev provides integrated practice optimization services including revenue cycle management, workflow efficiency enhancement, administrative burden reduction, and scheduling optimization. The company serves healthcare providers, clinical partners, and distributors across the United States. MedDev's regenerative solutions leverage amniotic membrane grafts containing growth factors and cytokines to promote cell proliferation, tissue regeneration, inflammatory modulation, and minimal immune response. The company emphasizes compliance-first operations, clinical research backing, and hands-on provider support. Their business model combines premium biologic products with comprehensive practice management services to optimize both patient outcomes and provider operations.

Prince Sterilization Services is an FDA-registered, ISO 13485-certified, and cGMP-compliant contract sterilization and depyrogenation provider serving pharmaceutical, medical device, and life sciences companies globally. Founded in 2017 by Dr. Daniel Prince and Dr. Derek Prince, the company operates eco-friendly sterilization facilities in Fairfield, New Jersey, adhering to ISO 17665 and EN285 standards. The company offers terminal sterilization via moist heat steam, dry heat, and vaporized hydrogen peroxide (VHP), along with depyrogenation and water-for-injection (WFI) rinsing services. Prince specializes in heat-labile product processing, bioburden-based cycle development, commercial-scale production, and emergency sterilization services. The SteriKit® family provides customizable, ready-to-use sterile kits and components—including vials, stoppers, and seals—certified as sterile, pyrogen-free, and particulate-free per USP standards.

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Apex Medical Technologies, Inc. is a specialized contract manufacturer and dip molding service provider founded in 1985, serving the medical device industry for over 40 years. The company specializes in thin-wall, elastomeric dip molding of non-latex components designed to address latex allergy concerns in medical devices. Apex offers comprehensive manufacturing services including custom dip molding, GMP contract manufacturing, tooling design, product development, prototyping, leak testing, cleanroom dip molding and assembly, and packaging. The company manufactures dip molded elastomeric components for medical devices, working with various materials to produce high-precision, thin-wall parts. Apex provides both prototype and production-scale manufacturing capabilities, supported by over four decades of experience and established relationships with medical device manufacturers. The company maintains quality standards appropriate for medical device production and operates cleanroom manufacturing facilities for contamination-sensitive applications. Services include complete project support from concept through finished product delivery.

Genesis Innovation Group is a U.S.-based medical device development and commercialization partner headquartered in Grand Rapids, Michigan. The company specializes in guiding medical device innovators from ideation through regulatory clearance and market launch. Genesis offers comprehensive services across five core pillars: (1) Ideation & Engineering—concept validation, prototype formation, product validation, and enterprise expansion; (2) Business & Finance—corporate governance, legal structuring, board formation, funding strategy, and financial reporting; (3) Manufacturing Expertise—including additive manufacturing, CNC machining, molding, raw material supply, novel material processing, forging, and coatings; (4) Regulatory & Quality—Class I–III device pathways, 510(k) and PMA clearance support, ISO 13485 quality system implementation, and essential document compliance; and (5) Market Strategy & Commercialization—inventory logistics, key opinion leader engagement, independent distributor networks, surgeon training, IRB and VA approvals, hospital and ASC contract facilitation, and clinical data collection. Genesis has successfully navigated the complex medical device development pathway multiple times and serves as both strategic advisor and partner to entrepreneurs and established companies seeking to bring innovative medical technologies to market. The firm leverages relationships with researchers, manufacturers, distributors, and physicians to accelerate development timelines and market penetration. Genesis has created subsidiary companies including Capitan Orthopedics, indicating active investment and development across specialty areas.