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  2. ISO 13485 - Wikipedia

    en.wikipedia.org/wiki/ISO_13485

    ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is a voluntary standard, [1] published by International Organization for Standardization (ISO) for the first time in 1996, and contains a comprehensive quality management system for the design and manufacture of medical devices.

  3. Quality management system - Wikipedia

    en.wikipedia.org/wiki/Quality_management_system

    The two primary, state of the art, guidelines for medical device manufacturer QMS and related services today are the ISO 13485 standards and the US FDA 21 CFR 820 regulations. The two have a great deal of similarity, and many manufacturers adopt QMS that is compliant with both guidelines.

  4. ISO 9000 family - Wikipedia

    en.wikipedia.org/wiki/ISO_9000_family

    ISO 13485:2016 is the medical industry's equivalent of ISO 9001. ISO 13485:2016 is a stand-alone standard. Because ISO 13485 is relevant to medical device manufacturers (unlike ISO 9001, which is applicable to any industry), and because of the differences between the two standards relating to continual improvement, compliance with ISO 13485 ...

  5. ModusLink Receives ISO 13485 Certification for Medical ... - AOL

    www.aol.com/news/2012-10-01-moduslink-receives...

    ModusLink Receives ISO 13485 Certification for Medical Device Manufacturers —Leading manufacturers of consumer-oriented medical devices certify ModusLink according to their ISO-based quality ...

  6. Design controls - Wikipedia

    en.wikipedia.org/wiki/Design_controls

    ISO 13485 is a voluntary standard that contains section 7.3 Design and Development recommending which procedures should be put in place by manufacturers in order to have a quality system that will comply with MDD 93/42/EEC and the MDR.

  7. Device Master Record - Wikipedia

    en.wikipedia.org/wiki/Device_Master_Record

    The sub-clause 4.2.3 of ISO 13485:2016 requires a manufacturer of medical device to establish a Technical file, similar to a device master record. The EU medical device regulation requires a manufacturer of a medical device to maintain a Technical documentation.

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