Medical Devices & Compliance 2026Updated

List of ISO 13485 Certified Medical Device Contract Manufacturers

Comprehensive database of contract manufacturers holding ISO 13485 certification for medical device production, covering Class I through III devices with verified quality management systems and FDA registration status.

Available Data Fields

Company Name

Headquarters

ISO 13485 Scope

FDA Device Classes

Manufacturing Capabilities

Cleanroom Classification

Facility Size (sq ft)

Number of Sites

Additional Certifications

Specializations

Contact Email

Website

Data Preview

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Company Name	Headquarters	FDA Device Classes	Manufacturing Sites
Jabil Healthcare	St. Petersburg, FL, USA	Class I, II, III	35 plants in 12 countries
Flex Ltd.	San Jose, CA, USA	Class I, II, III	21 medical sites in 13 countries
Spartronics	Williamsport, PA, USA	Class I, II, III	Multiple US facilities
PEKO Precision Products	Rochester, NY, USA	Class I, II	1 facility (375,000 sq ft)
Gilero (Sanner Group)	Pittsboro, NC, USA	Class I, II	Pittsboro + Greensboro, NC

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ISO 13485 Certified Contract Manufacturers for Medical Devices

ISO 13485 is the internationally recognized quality management system (QMS) standard specifically designed for organizations involved in the design, production, installation, and servicing of medical devices. As of 2023, over 32,900 valid ISO 13485 certificates have been issued globally, covering nearly 53,000 certified sites.

Why ISO 13485 Matters for Contract Manufacturing

For medtech startups and R&D teams sourcing contract manufacturers, ISO 13485 certification is more than a checkbox—it signals that a manufacturer maintains a compliant QMS capable of consistently meeting customer and regulatory requirements. This is especially critical given a major regulatory shift: the FDA's new Quality Management System Regulation (QMSR), effective February 2, 2026, fully harmonizes the FDA's quality system requirements with ISO 13485:2016.

Under the QMSR, manufacturers already certified to ISO 13485 will find FDA compliance significantly streamlined, making certified contract manufacturers even more valuable partners.

Key Selection Criteria

Device Classification Experience: Ensure the manufacturer has documented experience with your FDA device class. Class III devices require the most rigorous process controls and design history file management.
Cleanroom Capabilities: ISO 7 and ISO 8 cleanrooms are standard for many device assemblies. Verify the classification matches your product requirements.
Sterilization Services: In-house gamma, EO, or e-beam sterilization can significantly reduce lead times and supply chain risk compared to outsourced sterilization.
Regulatory Geography: If targeting multiple markets (FDA, EU MDR, Health Canada), look for manufacturers with MDSAP certification alongside ISO 13485.

Market Landscape

The medical device contract manufacturing market ranges from global EMS giants like Jabil (35 ISO 13485 plants across 12 countries) and Flex (21 dedicated medical sites) to specialized mid-size firms. Regional clusters exist in the US Midwest, Southern Germany, Ireland, Costa Rica, and Southeast Asia.

Tier	Typical Revenue	Characteristics
Tier 1 (Global EMS)	>$1B	End-to-end capabilities, global footprint, all device classes
Tier 2 (Regional)	$50M–$1B	Specialized expertise, multiple facilities, strong in specific device types
Tier 3 (Niche)	<$50M	Deep specialization (e.g., catheters, implants), often faster NPI cycles

Frequently Asked Questions

Q.How is ISO 13485 certification verified for each manufacturer?

At the time of your request, our AI crawls public sources including certification body databases, manufacturer websites, and regulatory registries to confirm current ISO 13485 certification status. Since certifications can lapse or be suspended, the data reflects what is publicly available at the time of collection.

Q.Does this dataset include manufacturers outside the United States?

Yes. The dataset covers ISO 13485 certified contract manufacturers globally, including major medtech manufacturing hubs in Europe, Southeast Asia, Central America, and beyond. You can filter by region or country to narrow results.

Q.Can I filter by specific device types like catheters or implants?

Yes. You can specify the device type, FDA class, and manufacturing processes you need (e.g., injection molding, CNC machining, catheter assembly) and the AI will return manufacturers with relevant capabilities.

Q.How does this differ from directories like ThomasNet or Qmed?

Traditional directories rely on self-reported profiles that may be outdated. Our service crawls the web in real time to gather current certification status, capabilities, and facility details, then structures the data into a consistent, comparable format.