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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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ISO 9001 for Small Businesses

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Medical Device Related Standards - Sub-Forum(s) Search this Forum
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Medical Device Quality Management Systems Standards - ISO 13485 and ISO 14969.
by KoD_RP
28th May 2016 03:35 PM Go to last post
1,996 15,054
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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 May 2016 02:30 PM Go to last post
217 1,838
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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.
27th May 2016 04:13 PM Go to last post
589 3,958
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IEC 62304 - Requirements for a development life cycle of medical device software, including medical device software risk management.
22nd May 2015 06:42 PM Go to last post
131 1,090
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Application of usability (human factors engineering) engineering to medical devices.
23rd June 2015 07:27 PM Go to last post
30 350
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Medical Device Related Standards not listed in the above sub-forums.
by Wayne
25th May 2016 03:44 PM Go to last post
240 1,579

 
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Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > Medical Devices, Medical Information Technology, Medical Software and Health Informatics


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