Join the Largest Private Label and Contract Manufacturing Group on LinkedIn

Register Company

Medical Device Contract Manufacturers and Medical Device Production Partners

Home > Medical > Medical Device

Last updated Sep 08, 2026

FDA medical device classification determines the regulatory pathway, manufacturing requirements, and documentation obligations for every device before a single unit is produced. A contract manufacturer’s experience must match your specific device class. A manufacturer experienced with Class I devices is not automatically qualified for Class II device production. This is the first and most important qualification question for any medical device brand. This page lists medical device contract manufacturers. Use the filters to compare by device class, certifications, and location.

Sterling offers end-to-end contract manufacturing for medical devices, handling everything from design and supply chain management to final assembly, quality assurance, and packaging. They provide clients with a single-partner solution,Show More
  • Visit Website
  • View Profile
NextPhase Medical Devices is a leading contract manufacturing partner specializing in low- to medium-volume complex electronic and disposable medical devices for OEMs across North America. Formed in 2017 from theShow More
  • Visit Website
  • View Profile
Established in 1982, HDA Technology, a family-owned-and-operated business, serves as a full-service engineering design firm specializing in electronic product development across various technology industries, including telecom, transportation, professional audio, Medical,Show More
  • Visit Website
  • View Profile
Formacoat LLC specializes in offering hydrophilic and custom medical device coating services, along with contract manufacturing for medical devices. Their coating services encompass inner and outer diameters, as well asShow More
  • Visit Website
  • View Profile
Founded in 1980 and headquartered in Saint Paul, Minnesota, Donatelle Plastics Incorporated specializes in the manufacturing of medical devices, offering customizable solutions in areas such as cardiac rhythm management, neuromodulation,Show More
  • Visit Website
  • View Profile
DeviceLab, located in Orange County, CA, is a leading contract medical device design and product development firm offering comprehensive services in mechanical engineering, electronics, software, industrial design, prototyping, manufacturing, FDAShow More
  • Visit Website
  • View Profile
Coghlin Companies, established in 1885, offers a range of services including engineering, contract manufacturing, global fulfillment, and aftermarket solutions. Our services are designed to cater to a consortium of capitalShow More
  • Visit Website
  • View Profile

What to Look for in a Medical Device Contract Manufacturer

Medical device contract manufacturing has regulatory requirements and quality system standards that go significantly beyond consumer goods manufacturing. These three criteria address the most important baseline qualification requirements.

FDA Device Classification and Pathway Experience

Class I devices are subject to general controls and most are exempt from premarket notification. Class II devices require 510(k) premarket notification demonstrating substantial equivalence to a predicate device before marketing. Class III devices require Premarket Approval with clinical evidence of safety and effectiveness. Your contract manufacturer must have specific experience with your device’s classification and the applicable market pathway. Confirm your manufacturer’s experience with your specific device class before development begins.

ISO 13485 Certification with Appropriate Scope

ISO 13485 is the quality management system standard specific to medical device manufacturers. The scope of the certification must cover your device type. A certification covering injection-molded plastic components does not automatically cover electronic medical devices or sterile products. Confirm your manufacturer’s ISO 13485 certification is current and that the scope covers your specific device category.

FDA Establishment Registration and QSR Compliance

All manufacturers producing devices for the US market must register their establishment annually with the FDA and comply with the Quality System Regulation under 21 CFR Part 820. Confirm your contract manufacturer holds current FDA establishment registration and maintains a quality system that addresses both ISO 13485 and FDA QSR requirements.

Key Certifications for Medical Device Contract Manufacturing

Medical device manufacturing certifications address both quality systems and market-specific regulatory requirements.

ISO 13485 certification is the international baseline for all medical device manufacturing. FDA establishment registration is required for all devices sold in the US. EU MDR compliance and CE marking are required for EU market access. ISO 14971 risk management is required as part of ISO 13485 compliance.

MOQs for Medical Device Contract Manufacturing

Medical device MOQs are highly variable by device complexity, regulatory class, and production method.

Class I disposable devices may have accessible MOQs starting at 1,000 to 10,000 units. Class II devices requiring 510(k) clearance involve significant pre-production investment for design validation, V&V testing, and regulatory submission before production MOQs are relevant.

Related Medical Device Manufacturing Resources

Browse all medical device manufacturers on Find My Manufacturer, or use the filters above to narrow by device class, certifications, and location.

See also: Medical Injection Molding Manufacturers | Medical Assembly Manufacturers | pharmaceutical manufacturers