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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ISO 13485 - Medical Device Quality Management System Requirements for Regulatory Purposes - (ISO 14969 has been replaced by ISO 13485:2016).
25th September 2018 02:08 AM Go to last post
2,302 17,251
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.
18th September 2018 02:58 AM Go to last post
264 2,237
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.
24th September 2018 01:34 PM Go to last post
741 4,732
IEC 62304 - Requirements for a development life cycle of medical device software, including medical device software risk management.
by Phil925
28th August 2018 06:05 PM Go to last post
160 1,252
Application of usability (human factors engineering) engineering to medical devices.
24th September 2018 07:39 PM Go to last post
44 452
Medical Device Related Standards not listed in the above sub-forums.
by lzanini
20th September 2018 03:46 AM Go to last post
303 1,880

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