2 verified machine shops in Texas 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 ISO 13485 certified. source
ISO 13485 & 9001 certified source
Fewer than three verified shops here yet — this page grows as more shops in the area are verified.
All machine shops in Texas · ISO 9001 in Texas · AS9100 in Texas