ISO 13485 machine shops in Ohio

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.

• Pemco Inc

  Cleveland, OHISO 13485

  ISO 13485 Quality Discipline source

• The Technology House, Ltd

  Streetsboro, OHISO 13485:2016

  Understanding that medical devices demand specialized expertise and require stringent industry standards, we’re certified to ISO 13485:2016, a comprehensive quality system standard for the design and manufacture of medical devices. source

• Western Enterprises, Inc.

  Westlake, OHISO 13485

  ISO 9001/ISO 13485 Registered Quality System certification. source

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