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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.
24th September 2018 05:17 PM Go to last post
3,927 24,008
This forum is for Health Canada regulations and other applicable regulations related to medical devices in Canada.
14th September 2018 03:33 PM Go to last post
160 872
SFDA regulations and other applicable regulations related to medical devices in China.
22nd September 2018 12:46 AM Go to last post
84 459
The 3 Medical Device Directives and other applicable regulations related to Medical Devices in the EU (European Union).
23rd September 2018 04:51 PM Go to last post
1,227 7,909
MHLW and PMDA regulations and other applicable regulations related to medical devices in Japan.
by v9991
9th September 2018 08:02 PM Go to last post
75 358
24th September 2018 05:17 PM Go to last post
1,769 10,469
Regulatory systems around the world different from the ones in the above sub-forums.
23rd September 2018 02:39 AM Go to last post
612 3,941
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 g_ehs
25th September 2018 08:34 PM Go to last post
3,816 27,818
ISO 13485 - Medical Device Quality Management System Requirements for Regulatory Purposes - (ISO 14969 has been replaced by ISO 13485:2016).
by Jean_B
25th September 2018 12:56 PM Go to last post
2,303 17,253
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 September 2018 10:48 AM Go to last post
264 2,239
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 Chronos
25th September 2018 09:10 AM Go to last post
741 4,734
IEC 62304 - Requirements for a development life cycle of medical device software, including medical device software risk management.
by g_ehs
25th September 2018 08:34 PM Go to last post
161 1,260
Application of usability (human factors engineering) engineering to medical devices.
24th September 2018 07:39 PM Go to last post
44 452
Medical Device Related Standards not listed in the above sub-forums.
by lzanini
20th September 2018 03:46 AM Go to last post
303 1,880
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.
28th August 2018 10:41 AM Go to last post
39 188
Other various Medical Device and Orthopedic related discussions.
10th September 2018 03:06 AM Go to last post
315 1,910
The MedAccred Program is an Industry Group.
by AndyN
21st August 2018 10:25 AM Go to last post
3 5

 
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