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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 mpfizer
21st August 2017 12:11 PM Go to last post
3,523 22,023
This forum is for Health Canada regulations and other applicable regulations related to medical devices in Canada.
7th August 2017 12:36 PM Go to last post
133 751
SFDA regulations and other applicable regulations related to medical devices in China.
by crumble
17th August 2017 05:45 AM Go to last post
76 421
The 3 Medical Device Directives and other applicable regulations related to Medical Devices in the EU (European Union).
21st August 2017 06:30 AM Go to last post
1,064 7,013
MHLW and PMDA regulations and other applicable regulations related to medical devices in Japan.
16th July 2017 11:09 AM Go to last post
67 331
by kreid
17th August 2017 10:09 AM Go to last post
1,619 9,837
Regulatory systems around the world different from the ones in the above sub-forums.
by mpfizer
21st August 2017 12:11 PM Go to last post
564 3,670
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 rothlis
19th August 2017 02:33 AM Go to last post
3,470 25,586
ISO 13485 - Medical Device Quality Management System Requirements for Regulatory Purposes - (ISO 14969 has been replaced by ISO 13485:2016).
19th August 2017 12:09 AM Go to last post
2,101 15,869
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.
by Marc
12th August 2017 06:19 AM Go to last post
244 2,075
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
16th August 2017 10:57 AM Go to last post
662 4,294
IEC 62304 - Requirements for a development life cycle of medical device software, including medical device software risk management.
by rothlis
19th August 2017 02:33 AM Go to last post
148 1,167
Application of usability (human factors engineering) engineering to medical devices.
by yodon
6th July 2017 10:50 AM Go to last post
36 407
Medical Device Related Standards not listed in the above sub-forums.
17th August 2017 11:35 PM Go to last post
279 1,774
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.
25th July 2017 06:32 PM Go to last post
33 140
Other various Medical Device and Orthopedic related discussions.
by Marc
11th August 2017 01:07 PM Go to last post
294 1,820

 
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