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Medical Device Related Standards

Medical devices standards, national and international. Standards are published by standards writing bodies (such as ISO and IEC internationally, ANSI, CEN, CENELEC, CSA and others nationally) and are generally voluntary. You can use standards to fulfill regulations, depending on the way the regulation uses standards.


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International Standards Bodies - World Wide Standards Bodies

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IRCA - International Register of Certified Auditors

SAE - Society of Automotive Engineers

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Medical Device Related Standards - Sub-Forum(s) Search this Forum
  Forum Last Post or Poll Vote Threads Posts
ISO 13485 - Medical Device Quality Management System Requirements for Regulatory Purposes - (ISO 14969 has been replaced by ISO 13485:2016).
by Julie O
26th September 2016 02:29 PM Go to last post
2,012 15,221
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.
21st September 2016 09:25 AM Go to last post
220 1,864
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
14th September 2016 11:07 AM Go to last post
601 3,998
IEC 62304 - Requirements for a development life cycle of medical device software, including medical device software risk management.
by yodon
9th September 2016 01:38 PM Go to last post
136 1,113
Application of usability (human factors engineering) engineering to medical devices.
2nd September 2016 11:16 AM Go to last post
33 367
Medical Device Related Standards not listed in the above sub-forums.
by Julie O
26th September 2016 02:54 PM Go to last post
249 1,624

 
Medical Device Related Standards - Discussion Threads Forum Tools Search this Forum
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