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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 June 2017 11:33 AM Go to last post
3,480 21,764
This forum is for Health Canada regulations and other applicable regulations related to medical devices in Canada.
17th May 2017 03:43 PM Go to last post
130 741
SFDA regulations and other applicable regulations related to medical devices in China.
by jawlong
21st June 2017 11:36 PM Go to last post
75 420
The 3 Medical Device Directives and other applicable regulations related to Medical Devices in the EU (European Union).
by Ronen E
26th June 2017 11:22 PM Go to last post
1,047 6,872
MHLW and PMDA regulations and other applicable regulations related to medical devices in Japan.
by jinglot
20th June 2017 02:06 PM Go to last post
67 330
21st June 2017 04:36 PM Go to last post
1,604 9,763
Regulatory systems around the world different from the ones in the above sub-forums.
27th June 2017 11:33 AM Go to last post
557 3,638
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.
26th June 2017 08:40 AM Go to last post
3,422 25,284
ISO 13485 - Medical Device Quality Management System Requirements for Regulatory Purposes - (ISO 14969 has been replaced by ISO 13485:2016).
by rob73
22nd June 2017 04:29 AM Go to last post
2,078 15,694
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.
25th June 2017 11:14 PM Go to last post
240 2,042
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.
26th June 2017 08:40 AM Go to last post
651 4,253
IEC 62304 - Requirements for a development life cycle of medical device software, including medical device software risk management.
by glork98
19th June 2017 08:29 PM Go to last post
146 1,151
Application of usability (human factors engineering) engineering to medical devices.
by Ronen E
6th May 2017 06:17 AM Go to last post
36 405
Medical Device Related Standards not listed in the above sub-forums.
by ryannh
19th June 2017 10:46 AM Go to last post
271 1,739
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.
by yodon
2nd June 2017 07:14 PM Go to last post
292 1,809

 
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