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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.
by rwend07
20th July 2017 03:51 PM Go to last post
3,496 21,834
This forum is for Health Canada regulations and other applicable regulations related to medical devices in Canada.
12th July 2017 10:24 AM Go to last post
131 742
SFDA regulations and other applicable regulations related to medical devices in China.
15th March 2017 01:31 PM Go to last post
75 418
The 3 Medical Device Directives and other applicable regulations related to Medical Devices in the EU (European Union).
by rwend07
20th July 2017 03:51 PM Go to last post
1,054 6,907
MHLW and PMDA regulations and other applicable regulations related to medical devices in Japan.
16th July 2017 11:09 AM Go to last post
67 331
20th July 2017 12:21 PM Go to last post
1,609 9,778
Regulatory systems around the world different from the ones in the above sub-forums.
19th July 2017 02:21 PM Go to last post
560 3,658
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.
by Mor628
21st July 2017 03:50 AM Go to last post
3,440 25,388
ISO 13485 - Medical Device Quality Management System Requirements for Regulatory Purposes - (ISO 14969 has been replaced by ISO 13485:2016).
by Mor628
21st July 2017 03:50 AM Go to last post
2,086 15,751
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.
19th July 2017 04:45 PM Go to last post
241 2,048
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.
19th July 2017 01:39 PM Go to last post
656 4,275
IEC 62304 - Requirements for a development life cycle of medical device software, including medical device software risk management.
by dukakis
19th July 2017 09:33 PM Go to last post
147 1,156
Application of usability (human factors engineering) engineering to medical devices.
by yodon
6th July 2017 10:50 AM Go to last post
36 407
Medical Device Related Standards not listed in the above sub-forums.
by Ronen E
21st July 2017 12:31 AM Go to last post
274 1,751
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.
17th March 2017 12:21 AM Go to last post
33 139
Other various Medical Device and Orthopedic related discussions.
21st July 2017 02:53 AM Go to last post
293 1,816

 
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