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Medical Device Assembly Manufacturers and Contract Medical Assembly Producers

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Medical device assembly requires traceability documentation, controlled environment production, and quality systems compliant with FDA 21 CFR Part 820 and ISO 13485. Every component and sub-assembly must be traceable through the production record to support any potential recall or field safety corrective action. A manufacturer without a documented traceability system is not appropriate for regulated medical device assembly regardless of production capability. This page lists medical assembly manufacturers. Use the filters to compare by device type, certifications, and location.

Delta Group Electronics Inc. is a U.S.-based Electronics Manufacturing Services (EMS) provider established in 1987, specializing in high-mix medium-volume to low-mix medium-quantity electronic manufacturing. Headquartered in Albuquerque, New Mexico, withShow More
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Syrma Johari Medtech
Syrma Johari MedTech is a leading electronic medical device contract manufacturer serving clients across global markets. With over 45 years of industry experience, we specialize in the design, development, engineering,Show More
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SMC Ltd
SMC Ltd. is a global contract manufacturing partner specializing in single-use and disposable medical devices for the pharmaceutical, medical, and diagnostics industries. With over 35 years of experience, SMC deliversShow More
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Access Bio is a global leader in in vitro diagnostics (IVD), dedicated to improving public health through the development, research, and manufacturing of high-quality diagnostic solutions. Specializing in rapid diagnosticShow More
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Regal Research & Mfg co. has emerged as a prominent provider of electromechanical contract manufacturing solutions in the United States, serving industries such as medical equipment, semiconductor equipment, EV charging,Show More
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AYUVENDS is a well-recognized brand name in the Ayurvedic field that offers authentic, pure, and effective Ayurvedic products for enhancing a healthy lifestyle. AyuVends is a leading brand that believesShow More
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Automated Assembly Corporation, based in Minnesota, USA, is a leading electronic contract manufacturer specializing in Roll-to-Roll (R2R) flexible printed circuit assembly. Their state-of-the-art facility and expertise in automation enable themShow More
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With a robust engineering background and extensive experience, Janco emerges as a premier custom contract manufacturer specializing in thermoforming and sealing medical trays for devices. Their mature Quality System, certifiedShow More
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What to Look for in a Medical Device Assembly Manufacturer

Medical device assembly requires documentation and traceability systems that go significantly beyond standard assembly manufacturing. These three criteria address the most important qualification requirements.

Component Traceability and Lot Control

Every component used in a medical device assembly must be traceable by lot number through the device’s production history record. This traceability system enables targeted recall if a component failure is identified in the field. A manufacturer without documented lot control for incoming components cannot support the device history record requirements under 21 CFR Part 820. Confirm your manufacturer maintains component-level lot traceability and can demonstrate their device history record system before production commitment.

ISO 13485 Quality System and FDA QSR Compliance

Both ISO 13485 and FDA 21 CFR Part 820 Quality System Regulation require documented processes covering purchasing controls, production controls, inspection and testing, nonconforming product control, and corrective and preventive action. Confirm your manufacturer holds current ISO 13485 certification appropriate for your device type and maintains FDA establishment registration for US market devices.

Clean Room and Controlled Environment Capability

Many medical device assemblies require production in classified clean rooms. The required classification depends on the device type and whether the assembly will be sterilized. Non-sterile device assemblies typically require ISO Class 7 or 8 environments. Assemblies for sterile final-packaged devices may require more stringent control. Confirm your manufacturer operates the appropriate production environment for your specific assembly requirements.

Key Certifications for Medical Assembly Manufacturers

Medical assembly certifications address quality system compliance and market access requirements.

ISO 13485 certification is the international baseline for medical device assembly. FDA establishment registration is required for assemblies used in US market devices. EU MDR compliance is required for EU market assemblies. IEC 60601 compliance is relevant for electro-medical device assemblies.

MOQs for Medical Device Assembly

Medical device assembly MOQs are highly variable by device complexity and validation requirements.

Simple disposable device assembly may start at 1,000 to 10,000 units per production run. Complex multi-component device assembly requires process validation before production release, adding significant pre-production time and cost.

Related Medical Manufacturing Resources

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

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