ISO 13485 machine shops in California
10 verified machine shops in California 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.
The shops — 10
Each shop's verified iso 13485 fact is quoted from its own website; open the shop for every other capability on record.
Advanced Machining Techniques, Inc.
Morgan Hill, CAISO 13485:2003We are certified to ISO 9001:2008, ISO 13485-2003 and AS9100. source
Airtronics Metal Products
Morgan Hill, CAISO 13485:2016ISO 13485:2016 CERTIFICATION source
Altest Corp
San Jose, CAISO 13485Altest 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
Azure Microdynamics, Inc.
Foothill Ranch, CAISO 13485:2016We are ISO 13485:2016 certified, and are an FDA Registered Facility. source
Delta Hi-tech
Chatsworth, CAISO 13485:2016Our ISO 9001:2015, AS9100D, and ISO 13485:2016 certifications underline our commitment to quality. source
Expedite Precision Works, Inc.
San Jose, CAISO 134852013 Acquired ISO 13485 Certification. source
Pencom
San Carlos, CAISO 13485ISO 13485 source
Peridot Corp
Pleasanton, CAISO 13485:2016ISO 13485.2016 CERTIFIED source
Rkl Technologies, Inc.
Corona, CAISO 13485:2016RKL Technologies is ISO13485 certified and a preferred supplier for some of the largest medical device companies in the world. We work hand-in-hand with engineers to ensure their designs are executed correctly and are optimized for manufacturability. source
Tamshell Corporation
Corona, CAISO 13485:2016Tamshell is an AS 9100D with ISO 9001:2015 Certified, ISO 13485:2016 Certified, and ITAR Registered precision machine shop. source
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