ISO 13485 metal fabrication shops in California

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 — 3

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

• B. T. Laser, Inc.

  Santa Clara, CAISO 13485:2016

  We are certified with ISO13485:2016, ISO9001:2015, and AS 9100D. source

• Bellows Manufacturing & Research, Inc.

  San Fernando, CAISO 13485

  Bellows Manufacturing and Research, Inc. is AS9100, ISO 9001 and ISO 13485 certified and EJMA (Expansion Joint Manufacturers Association, Inc.) compliant. We have a single standard all-encompassing Quality System. We do not subscribe to a quality detection program, but rather a methodology for building quality into our designs and products from inception to completion. source

• Gcx Instrument Mounting Systems

  Petaluma, CAISO 13485:2016

  OEM Solutions manufactured under our ISO 13485 certified quality system. source

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