Maintenance & Repair in California

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Hukui Biotechnology Co., Ltd. is a Contract Development and Manufacturing Organization (CDMO) established in 2013, specializing in electronic and medical device design, engineering, and manufacturing. Headquartered in Taipei, Taiwan, with GMP-certified production facilities in Zhubei, Taiwan and Chongqing, China, plus a U.S. business office in San Jose, California, Hukui leverages deep semiconductor and electronics industry expertise to serve medtech companies globally. The company offers three core solution areas: Medical AI Devices & Senior Care (telemedicine and AI-driven diagnostics), Medical Images & Endoscopy (ultrasound and endoscopic systems), and Point-of-Care Technologies (handheld diagnostic solutions). Hukui provides comprehensive services including design engineering, product development, small to large-scale manufacturing, and global regulatory affairs registration across FDA (U.S.), TFDA (Taiwan), and NMPA (China) jurisdictions. Manufacturing capabilities include regular working rooms, cleanrooms (Class 10,000 and Class 100,000), dedicated QC labs, and warehousing. The company is positioned as a partner for transforming groundbreaking technologies into fully engineered medical solutions, with emphasis on meticulous manufacturing processes and punctual delivery. Hukui participates in major industry exhibitions including MEDICA, MD&M, and regional trade shows.

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.

ARMM, Inc. is a medical device manufacturer specializing in high-quality disposable medical devices and contract manufacturing services. Based in Huntington Beach, California, the company produces sterile wound drains, suction and irrigation tubing sets, and specialized surgical devices in certified ISO 13485:2003 compliant clean room environments. ARMM offers comprehensive support across all project stages, from design and prototyping through full-scale production and assembly. The company's product portfolio includes MedDrain® thoracic and mediastinal silicone catheters, closed wound drains, SuperFlow® insufflation tubing sets, and EndoSI® suction/irrigation probes with wye tubing sets. Manufacturing processes employ skilled, trained assemblers with multiple quality inspections and strict adherence to Quality System Regulations. ARMM holds EC certification for sterile wound drain and tubing set manufacture, enabling European market access. The company positions itself as a cost-effective alternative for healthcare organizations seeking to expand manufacturing capabilities while reducing production costs.

Lumos Diagnostics is an ASX-listed developer, manufacturer, and distributor of point-of-care diagnostic technologies that deliver rapid, cost-effective diagnostic test solutions for healthcare professionals. The company specializes in rapid blood-based diagnostic assays and proprietary digital reader platforms that enable real-time assessment and differentiation of medical conditions at the point-of-care. FebriDx® is their flagship product—a rapid fingerstick blood test that aids differentiation between bacterial and non-bacterial infections, supporting clinical decision-making around antibiotic use. The company also offers ViraDx and reader platforms. Beyond proprietary products, Lumos provides comprehensive contract development and manufacturing services including strategic innovation and assay development, product development and manufacturing transfer using Lumos technology platforms, clinical and product validation, and commercial-scale manufacture of test strips and digital readers. Their in-house qualified team supports all stages from concept through commercialization, including medical, quality, and regulatory affairs. The US headquarters is located in Carlsbad, California, with a corporate office in Melbourne, Australia. Lumos serves global markets through qualified clinicians, healthcare systems, and diagnostic product manufacturers seeking custom point-of-care diagnostic solutions.

Altek Biotechnology Corporation is a leading digital imaging technology contract manufacturer (CDMO) specializing in OEM and ODM services for medical device brand companies. The company holds market-leading positions as the worldwide No. 1 BGM (blood glucose meter) CDMO and the worldwide No. 1 single-use endoscope CDMO. Core product categories include glucose meters, single-use (disposable) endoscopes, and intelligent insulin delivery systems. Altek offers comprehensive capabilities spanning the full product development lifecycle: concept development, R&D engineering, prototyping, product development, manufacturing, quality assurance, and process automation. The company specializes in miniaturization and digital imaging technologies, enabling manufacturers to bring innovative point-of-care and home-use diagnostic devices to market. With established long-term partnerships with tier-one global medical brands, Altek provides turnkey solutions from initial concept through mass production, emphasizing superior manufacturing processes, regulatory compliance, and product optimization. The company leverages expertise in automation and quality assurance to explore hidden compliance risks beyond baseline conformity requirements.

Therapak, LLC (now part of Resonant Clinical Solutions) is a specialized kitting and sample logistics provider serving clinical trials, medical device manufacturers, and diagnostic laboratories. The company designs and manufactures customized collection kits, insulated shipping containers, and sample transport solutions with thermal protection for temperature-sensitive materials. Therapak's end-to-end kitting solutions address three primary markets: drug development (clinical trial kitting), medical device manufacturing, and diagnostic laboratory services. Core product lines include insulated shippers (such as the DeepFreeze™ Shipping System), absorbent pouches and tube separators (Aqui-Pak™), and vacuum-sealed bags (95 kPa ShuttlePouch) for secure sample containment and transport. The company operates a customer portal (PASSPORT™) enabling order tracking and traceability. Therapak serves as a logistics and supply-chain partner for regulated industries requiring compliance with clinical trial protocols, diagnostic workflows, and medical device distribution standards. The company demonstrates capabilities in customized kit assembly, thermal logistics, and supply chain management for life sciences and healthcare sectors.

New Deantronics is a medical device developer and manufacturer founded in San Francisco in 1985, with engineering and manufacturing operations in Taiwan and a state-of-the-art 200,000 sq. ft. facility in Spanish Springs, Nevada. The company specializes in designing, developing, and manufacturing innovative surgical and medical devices for use in general surgery, neurosurgery, cardiology, orthopedics, and aesthetic medicine. New Deantronics is particularly known for miniaturized medical devices, including nano cameras used in minimally invasive surgical procedures. The company offers comprehensive services including design, development, manufacturing, packaging, sterilization, regulatory compliance, and post-market support. The company emphasizes quality, precision, and innovation, with a strong focus on FDA and ISO 13485 regulatory compliance. New Deantronics also operates medical device incubation centers to support startup innovation in the medical device sector.

Previon Solutions is a healthcare integration and compliance technology company serving health plans, managed care organizations, and healthcare systems. The company specializes in streamlining administrative and clinical programs through centralized software platforms and fulfillment services. Their core offerings include Previon PrISM, a campaign management platform designed for deploying repeatable program performance in preventative care initiatives; Previon Compliance™, which automates CMS-regulated document fulfillment and communication compliance; and white-labeled self-collection diagnostic kits that enable preventative care through at-home testing. Previon also provides assembly and fulfillment services, outreach solutions, and ongoing client support. The company operates on a consulting and implementation model, beginning with client consultation to understand desired outcomes, followed by comprehensive solution design including materials, branding, and engagement workflows. Staff training and post-implementation support are standard components of their service delivery. Previon serves diverse healthcare segments including virtual care organizations, managed care administrators, and health plans. The company is recognized as a top workplace in Orange County and maintains a client base that values ease of use, compliance automation, and responsive customer service.

A-1 Engineering USA is a California Department of Public Health (CDPH) licensed medical device manufacturer (License #78634) with over 20 years of experience in product development, prototyping, and manufacturing. The company specializes in end-to-end engineering services: conceptual design, CAD rendering, specifications, prototype development, in-house quality control testing, and US-based manufacturing. They hold FDA registration for Class I devices and comply with ISO 9001 quality management standards, UL, CE, and CSA certifications, and medical-grade safety standards (IEC 60601-3). A-1 Engineering manufactures under current good manufacturing practices (CGMPs) and provides post-sale warranty support and technical assistance for domestic and international distribution. The company manufactures NeurotriS microcurrent facial and body sculpting systems featuring bio-feedback monitoring loops. Services include design engineering, prototyping, quality control, manufacturing, branding support, and ongoing technical support.

Centerpiece Holdings LLC is a contract manufacturing and ETO sterilization services provider specializing in medical device supply chain solutions. The company operates a world-class ethylene oxide (ETO) sterilization facility in Tijuana, Mexico, with ten processing chambers, twelve aeration cells, and three large aeration rooms capable of high and low-volume processing. They provide integrated services including product and packaging design, design-for-manufacturability (DFM), sterilization compatibility analysis, contract manufacturing of Class II and III devices in certified Class 8 clean rooms, contract packaging (including bar sealing, tray sealing, custom form-fill-sealing, and foil flow wrapping), and sterile product warehousing with ambient and heated aeration capabilities. Centerpiece is FDA registered and ISO 13485 certified. Their manufacturing and sterilization operations are strategically located near the US-Mexico border, approximately 15 minutes from the US border, providing efficient logistics for North America's largest medical device manufacturing region. The company positions itself as a full-supply-chain solution provider rather than a standalone contract manufacturer, offering linked services that accelerate product innovation and commercialization from design through post-sterilization storage.

Invetech is a design, engineering, and contract manufacturing partner specializing in diagnostic instruments and cell therapy automation solutions. With over 35 years of experience, the company serves life sciences, biotech, and healthcare organizations, offering end-to-end capabilities from concept through commercialization. Core competencies include instrument design and development, contract manufacturing, custom workflow automation for cell therapy applications, and production-scale manufacturing solutions. Invetech supports product development across benchtop and point-of-care (POC) systems through large core laboratory instruments and mid- to high-throughput platforms. The company maintains a library of interchangeable modular subsystems designed to reduce development risk and improve product reliability. Service offerings encompass custom process automation, formulation and fill systems, and configurable automation platforms. Invetech works with diagnostics companies and cell therapy developers to transition technologies from clinical workflows to commercial manufacturing. The company positions itself as an extension of client engineering teams, integrating specialists in engineering, science, design, and program management.