1. Hello and Welcome to The Quality Forum Online...Continuing in the spirit of People Helping People !
    Dismiss Notice
Dismiss Notice
You must be a registered member in order to post messages and view/download attached files in this forum.
Click here to register.

Medical Device Standards and Regulations

Medical Device Standards and Regulations

  1. ISO 13485 and ISO 14969 – Medical Devices QMS

    ISO 13485 and ISO 14969 – Medical Devices Quality Management System
    Discussions:
    56
    Messages:
    396
    Latest: Real Registrar? Andy Nichols, Apr 16, 2018
    RSS
  2. ISO 14971 - Medical Devices Risk Management

    ISO 14971 - Application of Risk Management to Medical Devices
    Discussions:
    6
    Messages:
    50
    RSS
  3. IEC 60601 - Medical Electrical Equipment Safety

    IEC 60601 - Medical Electrical Equipment Safety Standards Series
    Discussions:
    17
    Messages:
    63
    RSS
  4. IEC 62304 - Medical Device Software

    IEC 62304 - Medical Device Software - Software Life Cycle Processes
    Discussions:
    3
    Messages:
    20
    RSS
  5. IEC 62366 - Medical Devices Usability Engineering

    IEC 62366 - Application of Usability Engineering to Medical Devices
    Discussions:
    2
    Messages:
    8
    Latest: Usability procedure yodon, Apr 3, 2018
    RSS
  6. Canada Medical Device Regulations

    Canada Medical Device Regulations
    Discussions:
    1
    Messages:
    6
    RSS
  7. China Medical Device Regulations

    China Medical Device Regulations
    Discussions:
    5
    Messages:
    23
    RSS
  8. EU Medical Device Regulations

    European Union Medical Device Regulations
    Discussions:
    30
    Messages:
    137
    Latest: clinical evaluation riri1912, Feb 6, 2018
    RSS
  9. US Medical Device Regulations

    United States Medical Device Regulations
    Discussions:
    22
    Messages:
    72
    RSS
  10. Other Medical Device Regulations World-Wide

    Other Medical Device Regulations World-Wide
    Discussions:
    12
    Messages:
    36
    Latest: Product Branding Change indicator, Sep 7, 2017
    RSS