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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.
28th May 2017 05:26 AM Go to last post
3,461 21,640
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
2nd May 2017 01:23 AM Go to last post
75 419
The 3 Medical Device Directives and other applicable regulations related to Medical Devices in the EU (European Union).
28th May 2017 05:26 AM Go to last post
1,038 6,800
MHLW and PMDA regulations and other applicable regulations related to medical devices in Japan.
26th April 2017 08:53 AM Go to last post
66 329
27th May 2017 09:58 PM Go to last post
1,597 9,731
Regulatory systems around the world different from the ones in the above sub-forums.
by tibon74
21st May 2017 05:05 PM Go to last post
555 3,620
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 relad
28th May 2017 07:19 AM Go to last post
3,399 25,179
ISO 13485 - Medical Device Quality Management System Requirements for Regulatory Purposes - (ISO 14969 has been replaced by ISO 13485:2016).
by relad
28th May 2017 07:19 AM Go to last post
2,071 15,649
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.
5th May 2017 09:15 AM Go to last post
239 2,037
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
26th May 2017 06:48 AM Go to last post
642 4,224
IEC 62304 - Requirements for a development life cycle of medical device software, including medical device software risk management.
by yodon
25th May 2017 04:07 PM Go to last post
144 1,140
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 planB
26th May 2017 04:21 AM Go to last post
267 1,724
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 pkost
19th May 2017 03:06 PM Go to last post
291 1,802

 
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