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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 rjhill
21st July 2018 05:28 PM Go to last post
3,839 23,642
This forum is for Health Canada regulations and other applicable regulations related to medical devices in Canada.
3rd July 2018 12:32 AM Go to last post
149 839
SFDA regulations and other applicable regulations related to medical devices in China.
by alyona
16th July 2018 04:59 AM Go to last post
83 451
The 3 Medical Device Directives and other applicable regulations related to Medical Devices in the EU (European Union).
by Woodray
21st July 2018 03:47 PM Go to last post
1,193 7,747
MHLW and PMDA regulations and other applicable regulations related to medical devices in Japan.
11th July 2018 12:11 PM Go to last post
74 354
by rjhill
21st July 2018 05:28 PM Go to last post
1,734 10,358
Regulatory systems around the world different from the ones in the above sub-forums.
by katmie
29th June 2018 06:42 AM Go to last post
606 3,893
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.
20th July 2018 05:22 PM Go to last post
3,750 27,388
ISO 13485 - Medical Device Quality Management System Requirements for Regulatory Purposes - (ISO 14969 has been replaced by ISO 13485:2016).
20th July 2018 05:22 PM Go to last post
2,274 17,006
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.
260 2,199
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 yodon
19th July 2018 04:43 PM Go to last post
721 4,642
IEC 62304 - Requirements for a development life cycle of medical device software, including medical device software risk management.
14th June 2018 01:54 PM Go to last post
158 1,239
Application of usability (human factors engineering) engineering to medical devices.
17th July 2018 02:32 PM Go to last post
42 448
Medical Device Related Standards not listed in the above sub-forums.
17th July 2018 11:14 AM Go to last post
295 1,854
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.
27th June 2018 10:27 AM Go to last post
37 174
Other various Medical Device and Orthopedic related discussions.
20th July 2018 07:46 AM Go to last post
308 1,889

 
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