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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.
1st March 2017 12:13 PM Go to last post
3,392 21,156
This forum is for Health Canada regulations and other applicable regulations related to medical devices in Canada.
by DannyK
26th February 2017 11:45 PM Go to last post
127 724
SFDA regulations and other applicable regulations related to medical devices in China.
21st February 2017 03:19 AM Go to last post
75 416
The 3 Medical Device Directives and other applicable regulations related to Medical Devices in the EU (European Union).
1st March 2017 12:13 PM Go to last post
1,006 6,574
MHLW and PMDA regulations and other applicable regulations related to medical devices in Japan.
19th December 2016 02:51 PM Go to last post
63 324
by Ronen E
27th February 2017 07:25 PM Go to last post
1,575 9,582
Regulatory systems around the world different from the ones in the above sub-forums.
by Mor628
27th February 2017 01:24 AM Go to last post
546 3,536
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 al40
1st March 2017 01:58 PM Go to last post
3,346 24,782
ISO 13485 - Medical Device Quality Management System Requirements for Regulatory Purposes - (ISO 14969 has been replaced by ISO 13485:2016).
by al40
1st March 2017 01:58 PM Go to last post
2,052 15,488
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.
16th February 2017 04:55 AM Go to last post
228 1,910
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 Pads38
27th February 2017 06:06 AM Go to last post
630 4,186
IEC 62304 - Requirements for a development life cycle of medical device software, including medical device software risk management.
30th November 2016 02:57 AM Go to last post
139 1,131
Application of usability (human factors engineering) engineering to medical devices.
by yodon
27th February 2017 10:44 AM Go to last post
35 378
Medical Device Related Standards not listed in the above sub-forums.
by planB
20th February 2017 05:19 AM Go to last post
262 1,689
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 shimonv
20th February 2017 02:25 AM Go to last post
33 138
Other various Medical Device and Orthopedic related discussions.
by Ronen E
3rd February 2017 08:48 PM Go to last post
285 1,766

 
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