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Medical Devices, Medical Information Technology, Medical Software and Health Informatics

Medical Device, Medical Information Technology, Medical Software and Health Informatics and related discussion topics.


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Medical Devices, Medical Information Technology, Medical Software and Health Informatics - Sub-Forum(s) Search this Forum
  Forum Last Post or Poll Vote Threads Posts
Medical device regulations around the world. Regulations are laws set by a regulatory authority of a country or region and are generally mandatory.
27th May 2018 06:26 AM Go to last post
3,786 23,367
This forum is for Health Canada regulations and other applicable regulations related to medical devices in Canada.
by RA Guy
4th May 2018 10:32 AM Go to last post
149 837
SFDA regulations and other applicable regulations related to medical devices in China.
5th March 2018 09:45 AM Go to last post
81 446
The 3 Medical Device Directives and other applicable regulations related to Medical Devices in the EU (European Union).
27th May 2018 06:26 AM Go to last post
1,167 7,590
MHLW and PMDA regulations and other applicable regulations related to medical devices in Japan.
by shimonv
11th May 2018 04:14 AM Go to last post
73 353
24th May 2018 12:31 PM Go to last post
1,714 10,261
Regulatory systems around the world different from the ones in the above sub-forums.
by planB
22nd May 2018 03:36 PM Go to last post
602 3,880
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.
25th May 2018 11:42 PM Go to last post
3,696 27,031
ISO 13485 - Medical Device Quality Management System Requirements for Regulatory Purposes - (ISO 14969 has been replaced by ISO 13485:2016).
25th May 2018 11:42 PM Go to last post
2,241 16,780
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.
9th May 2018 05:57 PM Go to last post
257 2,179
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 May 2018 09:11 PM Go to last post
710 4,572
IEC 62304 - Requirements for a development life cycle of medical device software, including medical device software risk management.
by rothlis
5th May 2018 07:25 PM Go to last post
156 1,224
Application of usability (human factors engineering) engineering to medical devices.
by tazer
25th May 2018 12:06 PM Go to last post
40 433
Medical Device Related Standards not listed in the above sub-forums.
by Mor628
22nd May 2018 03:48 AM Go to last post
292 1,843
Information Technology used in medicine including includes topics (which are used interchangeably sometimes) such as medical Information technology, medical software (software used in healthcare) and health informatics, including Health Information and Communications Technology (ICT). Examples are standards from the IEC 80001 series and the works of ISO TC 215.
21st May 2018 07:16 AM Go to last post
36 166
Other various Medical Device and Orthopedic related discussions.
27th May 2018 08:32 AM Go to last post
307 1,877

 
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