Certifications354 companies

ISO 13485 Certified Manufacturers in the U.S.

ISO 13485 is the quality management standard for medical device manufacturing. The companies below state ISO 13485 certification in their public information or have it verified with Noramark. Confirm the certificate and its scope with the shop before you order.

Listings come from each company’s public information and may be incomplete, so confirm capabilities, materials and certifications with the shop before you commit. The fastest way to get quotes is one request: attach your drawing (PDF or STEP) or describe the part, and Noramark routes it to U.S. shops that fit.

The most listings are in California (53), Minnesota (28), Illinois (24) and Massachusetts (24).

Jamestown Plastics, Inc.

Noramark member
Brocton, NY · Machining, Plastics & composites fabrication, Plastics & composites

Industries: Automotive, Consumer Products, Industrial Equipment, Medical

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Boedeker Plastics

Shiner, TX · Machining, Grinding, Injection molding, Deburring

Industries: Aerospace, Automotive, Food Processing, Medical

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CENTRAL PLASTICS

Tracy, CA · Welding, Metal stamping, Injection molding, Blow molding

Industries: Aerospace, Defense, Energy, Medical

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Techmetals, Inc.

Manage, OH · Anodizing, Nickel plating, Chrome plating, NDT: dye penetrant

Industries: Aerospace, Automotive, Defense, Energy

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By process

ISO 13485 Certified Machine Shops · 78ISO 13485 Certified Injection Molders · 49

Other certifications

ISO 9001 · 3,168AS9100 · 804IATF 16949 · 166Nadcap · 119