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Medical Device Related Standards - Sub-Forum(s) Search this Forum
  Forum Last Post or Poll Vote Threads Posts
Medical Device Quality Management Systems Standards - ISO 13485 and ISO 14969
by CarlyH
23rd July 2014 06:46 PM Go to last post
1,867 14,083
ISO 14971 - Medical Device Risk Management and Hazard Control: Identifying and controlling the risks and the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices.
4th July 2014 09:12 AM Go to last post
185 1,590
The IEC 60601 standards series covers safety and performance issues of medical electrical equipment, and also topics such as EMC and alarms. This sub-forum includes collateral (IEC 60601-1-X) and particular (60601-2-x) standards.
23rd July 2014 09:02 AM Go to last post
509 3,484
IEC 62304, Medical device software - Software life cycle processes. Requirements for a development life cycle of medical device software, including medical device software risk management.
by Gargi
3rd July 2014 01:03 AM Go to last post
120 1,025
IEC 62366 - Medical devices - Application of usability engineering to medical devices. Standard for usability (human factors engineering) issues for medical devices.
3rd July 2014 08:53 AM Go to last post
28 322
by Raffy
22nd July 2014 08:43 PM Go to last post
206 1,382
This is to help associate medical device forums in the Cove. There are the ISO and IEC standards forums and a separate FDA related forum.
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