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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 Ronen E
30th September 2014 06:53 PM Go to last post
1,886 14,212
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.
30th September 2014 10:19 AM Go to last post
191 1,666
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.
by Pads38
30th September 2014 04:43 AM Go to last post
527 3,637
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 yodon
15th September 2014 10:10 AM Go to last post
123 1,039
IEC 62366 - Medical devices - Application of usability engineering to medical devices. Standard for usability (human factors engineering) issues for medical devices.
7th August 2014 02:35 AM Go to last post
28 325
by Ronen E
1st October 2014 01:18 AM Go to last post
216 1,443

 
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