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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 noorain
13th December 2017 01:22 AM Go to last post
3,615 22,594
This forum is for Health Canada regulations and other applicable regulations related to medical devices in Canada.
by DannyK
9th December 2017 11:05 PM Go to last post
142 802
SFDA regulations and other applicable regulations related to medical devices in China.
by Gamula
11th December 2017 09:50 AM Go to last post
80 441
The 3 Medical Device Directives and other applicable regulations related to Medical Devices in the EU (European Union).
by noorain
13th December 2017 01:22 AM Go to last post
1,096 7,231
MHLW and PMDA regulations and other applicable regulations related to medical devices in Japan.
by fialor
2nd November 2017 05:13 AM Go to last post
69 337
12th December 2017 01:25 PM Go to last post
1,652 10,015
Regulatory systems around the world different from the ones in the above sub-forums.
by noorain
7th December 2017 02:50 AM Go to last post
576 3,768
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
12th December 2017 09:41 PM Go to last post
3,559 26,195
ISO 13485 - Medical Device Quality Management System Requirements for Regulatory Purposes - (ISO 14969 has been replaced by ISO 13485:2016).
by Mor628
12th December 2017 09:41 PM Go to last post
2,163 16,305
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 locutus
6th November 2017 07:06 AM Go to last post
250 2,123
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 HenryC
12th December 2017 06:43 PM Go to last post
675 4,367
IEC 62304 - Requirements for a development life cycle of medical device software, including medical device software risk management.
17th November 2017 06:33 AM Go to last post
151 1,179
Application of usability (human factors engineering) engineering to medical devices.
7th November 2017 09:35 AM Go to last post
38 424
Medical Device Related Standards not listed in the above sub-forums.
by clupin
5th December 2017 10:24 AM Go to last post
282 1,797
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.
by csa14
8th December 2017 05:20 AM Go to last post
35 159
Other various Medical Device and Orthopedic related discussions.
by rob73
8th December 2017 04:30 AM Go to last post
300 1,852

 
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