4 verified machine shops in San Jose, CA hold ISO 13485 certification; each fact below links to the sentence on the shop's own site.
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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.
Each shop's verified iso 13485 fact is quoted from its own website; open the shop for every other capability on record.
We are certified to ISO 9001:2008, ISO 13485-2003 and AS9100. source
ISO 13485:2016 CERTIFICATION source
Altest Corporation is fully ISO 13485 certified, meaning our quality management systems meet the rigorous regulatory requirements necessary to design and manufacture safe, reliable electronics for the healthcare industry. source
2013 Acquired ISO 13485 Certification. source
All machine shops in San Jose · ISO 13485 machine shops in California · ISO 9001 in San Jose · AS9100 in San Jose