2 verified metal fabrication shops in Ohio 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.
APS Materials, Inc. is ISO 13485:2016 certified, demonstrating our commitment to meeting the strict quality and regulatory requirements of the medical device industry. source
As an ISO 13485 certified company, we serve the medical component, device, and equipment manufacturing industry by providing high-purity precious metals, non-precious materials, and medical-grade brazing alloys. source
Fewer than three verified shops here yet — this page grows as more shops in the area are verified.
All metal fabrication shops in Ohio · ISO 9001 in Ohio · AS9100 in Ohio · CMMC in Ohio