ISO 13485 - Medical Device Manufacturers QMS

 

ISO 13485 is, effectively, ISO 9001 specifically for medical device manufacturers.

ISO 13485 incorporates ISO 9001 but adds or amends relevant sections to emphasise a risk management process to meet customer and regulatory requirements.

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QMS ISO 9001 for Medical Devices ISO 13485 certification

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ISO 9001, ISO 14001, ISO 45001, FSSC 22000, ISO 22000, HACCP, ISO 27001, ISO 55001 and more