1. This site uses cookies. By continuing to use this site, you are agreeing to our use of cookies. Learn More.
  2. 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:
    47
    Messages:
    335
    Latest: 13485 and Signed Documents Vintage Goose, Apr 28, 2017 at 9:56 AM
    RSS
  2. ISO 14971 - Medical Devices Risk Management

    ISO 14971 - Application of Risk Management to Medical Devices
    Discussions:
    5
    Messages:
    47
    Latest: Risk Analysis Checklist? ncwalker, Dec 5, 2016
    RSS
  3. IEC 60601 - Medical Electrical Equipment Safety

    IEC 60601 - Medical Electrical Equipment Safety Standards Series
    Discussions:
    14
    Messages:
    54
    RSS
  4. IEC 62304 - Medical Device Software

    IEC 62304 - Medical Device Software - Software Life Cycle Processes
    Discussions:
    2
    Messages:
    15
    RSS
  5. IEC 62366 - Medical Devices Usability Engineering

    IEC 62366 - Application of Usability Engineering to Medical Devices
    Discussions:
    1
    Messages:
    4
    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:
    26
    Messages:
    129
    RSS
  9. US Medical Device Regulations

    United States Medical Device Regulations
    Discussions:
    22
    Messages:
    68
    RSS
  10. Other Medical Device Regulations World-Wide

    Other Medical Device Regulations World-Wide
    Discussions:
    11
    Messages:
    32
    RSS