ACTIVE MEDICAL DEVICES
IMPLANT MEDICAL DEVICES
DISPOSABLE MEDICAL DEVICES
SOFTWARE MEDICAL DEVICES
IVD MEDICAL DEVICES

What are the Medical Device family standards?

ISO 13485:2016 - Medical Devices - QMS Requirements for Regulatory Purposes
ISO 14971 - Medical Devices - Application of Risk Management to Medical Devices
ISO/TR 14969:2004 - Medical Devices - Guidance on the Application of ISO 13485:2003
ISO 9000:2005 - QMS - Fundamentals and Vocabulary
ISO 62304:2009 - Medical Device software life cycle requirements

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