Maintenance & Repair in Florida

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.

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.

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.

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.

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.

B & M Precision, Inc. is a surgical-grade precision manufacturing company based in Ruskin, Florida, specializing in medical device components and surgical instruments. Founded in 1978, the company operates a 240,000 square-foot facility with over 340 employees and more than $100 million in manufacturing equipment. B & M Precision provides comprehensive CNC machining services including CNC milling and turning, Swiss screw machining, laser welding and cutting, wire and sinker EDM, tool and burr grinding, centerless grinding, and electropolishing with passivation and deburring capabilities. The company manufactures precision surgical blades, burrs, and custom components for leading medical device manufacturers and holds U.S. Government Contractor status. ISO 13485:2016 certified and FDA-compliant, B & M Precision delivers high-volume, tight-tolerance medical components with zero-defect quality standards. Services encompass full-service manufacturing from raw materials through finished product, with engineering support, continuous process innovation, and a two-shift production schedule to meet demanding timelines. The company serves the medical device industry with patented device manufacturing and strict compliance standards.

NDH Medical, Inc. is a contract medical device manufacturer specializing in custom extrusion and injection molding of tubing and related components for medical applications. The company produces single-lumen paratubing, multi-lumen tubing, coextruded tubing, taper (bump) tubing, braid-reinforced tubing, and wire/coil jacketing. In addition to extrusion capabilities, NDH Medical offers insert molding, injection molding, pad printing, assembly services, and in-house tooling design and fabrication. The company serves medical device OEMs and contract manufacturers requiring precision polymeric tubing and molded components. NDH Medical holds ISO 13485 certification (FM 620542), demonstrating compliance with medical device quality management standards. The company exhibits at major medical device manufacturing trade shows and maintains facilities in St. Petersburg, Florida.

Command Medical Products, LLC is a contract manufacturing solutions provider specializing in sub-assembly and sterile single-use medical devices for the medical and life science industries. The company operates three ISO Class 7 cleanrooms and employs 247 staff, with 19 years of industry experience. Core service lines include medical device assembly and packaging (sterile and non-sterile), sterilization management with value-added services, production transfer for established high-volume products, RF welding for bag configurations, and medical-grade tube extrusion (single/multi-lumen, thermal bonded paratubing, bubble tubing). Products are packaged in cut-lengths, coils, or hubless coils per customer specifications. Command Medical supports dock-to-stock finished goods delivery and operates a full cycle manufacturing solution with quality assurance and compliance frameworks. The company holds ISO 13485 certification and maintains comprehensive quality management systems. Services are tailored to precision requirements and regulatory compliance standards demanded by medical device OEMs and contract manufacturers across multiple therapeutic areas.

Endo-Therapeutics, Inc. is a leading U.S.-based designer, developer, and manufacturer of Class I and Class II single-use endoscopic instruments with over 30 years of experience. Headquartered in Clearwater, Florida, the company specializes in manufacturing millions of high-quality biopsy forceps, polypectomy snares, and related endoscopic accessories used by hospitals and surgical centers worldwide. Core product categories include tissue acquisition instruments (biopsy forceps, brushes), hemostasis devices (needles, multi-band ligators), foreign body retrieval tools, and miscellaneous endoscopic accessories. Beyond direct product manufacturing, Endo-Therapeutics offers comprehensive contract design and manufacturing services, procedure-specific product development, and OEM partnerships for medical device companies seeking endoscopic instrument solutions. The company maintains FDA compliance and domestic manufacturing capabilities, positioning itself as a trusted supplier for gastroenterology, bronchoscopy, laryngoscopy, and other endoscopic procedures.

J&B Medical is a family-owned healthcare supplier founded in 1996, operating as a recognized market leader in medical consumables, devices, and support services. The company distributes insurance-covered medical supplies, emergency first responder supplies, medical and surgical supplies, homecare products, and veterinary medical supplies. Primary product focus includes incontinence supplies (particularly through state insurance programs), diabetic management supplies (insulin pumps, continuous glucose monitors such as Dexcom6 and OmniPod5), and general medical/surgical consumables. J&B Medical operates multiple complementary business units: an insurance member portal for ordering and account management, emergency medical supply distribution (EMS), medical and surgical supply retail, telehealth services via affiliated HNC Virtual Solutions, and a veterinary supply division (J&B Pet Source). The company emphasizes customer service with insurance verification assistance, order tracking, prescription coordination with healthcare providers, and rapid fulfillment. Services include sole source program management, national managed care contracts, and technology solutions. J&B Medical serves individual consumers, insurance members, emergency responders, and healthcare facilities across the United States, with demonstrated expertise in managing complex insurance authorizations and fulfillment logistics.

Denterprise International is a registered FDA-exclusive importer and distributor of dental imaging equipment with 34 years of industry experience (founded 1989). The company specializes in sourcing, importing, and distributing innovative dental technology products to dental dealerships and practitioners across North America. Core business functions include FDA 510(k) submission consulting, medical device regulatory registration services, warehousing and logistics, and dealer/distributor network development. Product portfolio spans intraoral cameras (MiniCam USB2, iCAM HD), portable digital X-ray systems (Xray2Go, MobileX, QuickRay), intraoral scanners (Runyes, Cobra), and digital imaging accessories. Denterprise serves as a connector between manufacturers seeking US market entry and dental equipment dealers. The company maintains FDA registration and offers consulting services to help international manufacturers navigate regulatory pathways for market entry. Operational model emphasizes providing cost-effective alternatives to high-end branded equipment while maintaining clinical quality standards. Target markets include independent dental practices, group practices, and dental equipment dealerships seeking innovative, competitively priced imaging solutions.

Quick Aid Safety is a B2B medical supplies and personal protective equipment (PPE) sourcing and distribution company based in Clearwater, Florida. The company sources, designs, and distributes FDA-approved products to wholesale and retail markets through an extensive network of domestic and international manufacturing partners. Quick Aid specializes in first aid kits and components, industrial safety products (masks, thermometers, gowns), topical medications (hand sanitizers, ointments, burn creams), and adventure safety equipment. The company operates two 50,000 square-foot warehouses in Clearwater and partners with leading 3PL providers including RIM Logistics, TXR, and C.H. Robinson to ensure rapid supply chain fulfillment and customs/FDA clearance. Quick Aid emphasizes rapid response times, FDA-approved product sourcing, ethical manufacturing practices, and scalable production capacity to serve major distributors including Grainger, Fastenal, and Vallen.

Dannik is an FDA-registered, ISO 13485-certified medical device manufacturer specializing in product design, development, and manufacturing of minimally invasive surgical instruments and laparoscopic solutions. The company focuses on surgeon-centric design and innovation for endoscopic and laparoscopic surgical tools, including specimen retrieval devices. Dannik operates as an OEM partner for leading endo-mechanical firms, providing private-label manufacturing and regulatory support services. The company combines experienced product development expertise with patient care focus to deliver best-in-class surgical instruments for minimally invasive procedures.

Surgical Resources Group, LLC is a B2B surgical supply distributor and healthcare solutions provider based in Clearwater, Florida. The company specializes in cost-recovery and cost-savings solutions on high-volume surgical devices, offering discounted pricing on thousands of surgical items from over 30 manufacturers. SRG's core business includes wholesale distribution of surgical supplies with no minimum orders, flexible payment terms, and overnight to ground shipping options. Product subspecialties encompass endo-mechanicals, energy devices, fixation devices, OB/GYN devices, hernia mesh, orthopedic implants, sports medicine devices, urology supplies, wound care products, and bariatric surgery instruments. Beyond traditional surgical supply distribution, SRG provides business solutions including SupplyAssist (mobile device barcode scanning applications) and managed IT services for healthcare facilities. The company emphasizes inventory management and team development services. SRG is a member of the USF Health LIFT Community and maintains partnerships with nonprofits including Advocates for World Health (AWH) and Ssubi, focusing on medical supply sustainability and global healthcare access. The company holds a BBB accreditation and offers flexible ordering through phone, fax, email, and online channels. Products are available by individual units, boxes, and cases with guaranteed low prices and bulk order discounts.