ISO 13485 machine shops in San Francisco

ISO 13485 is the quality-management standard for medical devices — design controls, traceability and risk management for regulated parts.

Ask for the certificate scope; a medical OEM will also want to know about validation, lot traceability and cleanroom or clean-packaging capability.

The shops — 2

Each shop's verified iso 13485 fact is quoted from its own website; open the shop for every other capability on record.

• Pencom

  San Carlos, CAISO 13485

  ISO 13485 source

• Peridot Corp

  Pleasanton, CAISO 13485:2016

  ISO 13485.2016 CERTIFIED source

Fewer than three verified shops here yet — this page grows as more shops in the area are verified.

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