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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.
20th January 2017 11:36 PM Go to last post
3,366 20,971
This forum is for Health Canada regulations and other applicable regulations related to medical devices in Canada.
by DannyK
12th January 2017 01:32 PM Go to last post
126 719
SFDA regulations and other applicable regulations related to medical devices in China.
by shimonv
18th January 2017 04:17 AM Go to last post
73 403
The 3 Medical Device Directives and other applicable regulations related to Medical Devices in the EU (European Union).
20th January 2017 11:36 PM Go to last post
996 6,500
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
20th January 2017 12:08 AM Go to last post
1,564 9,513
Regulatory systems around the world different from the ones in the above sub-forums.
18th January 2017 10:04 PM Go to last post
544 3,512
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.
21st January 2017 01:54 PM Go to last post
3,326 24,640
ISO 13485 - Medical Device Quality Management System Requirements for Regulatory Purposes - (ISO 14969 has been replaced by ISO 13485:2016).
20th January 2017 09:35 AM Go to last post
2,042 15,409
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.
17th January 2017 10:42 AM Go to last post
226 1,900
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.
21st January 2017 01:54 PM Go to last post
625 4,148
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 mvroops
11th January 2017 10:39 AM Go to last post
34 374
Medical Device Related Standards not listed in the above sub-forums.
by alonFAI
18th January 2017 05:59 PM Go to last post
260 1,678
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 paulag
5th December 2016 09:11 AM Go to last post
30 128
Other various Medical Device and Orthopedic related discussions.
by Marc
23rd December 2016 09:09 AM Go to last post
283 1,755

 
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