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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

Quality Digest

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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ISO 13485 - Medical Device Quality Management System Requirements for Regulatory Purposes - (ISO 14969 has been replaced by ISO 13485:2016).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 Dtbal
17th September 2017 11:50 AM Go to last post
2,113 15,945
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.
by Ninja
12th September 2017 01:24 PM Go to last post
248 2,101
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 shimonv
19th September 2017 06:56 AM Go to last post
666 4,312
IEC 62304 - Requirements for a development life cycle of medical device software, including medical device software risk management.
by shimonv
12th September 2017 10:45 AM Go to last post
149 1,169
Application of usability (human factors engineering) engineering to medical devices.
29th August 2017 01:18 PM Go to last post
37 411
Medical Device Related Standards not listed in the above sub-forums.
by Bryce_S
14th September 2017 08:00 PM Go to last post
279 1,777

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