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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 Ronen E
28th April 2017 07:13 PM Go to last post
3,445 21,507
This forum is for Health Canada regulations and other applicable regulations related to medical devices in Canada.
by Marc
24th April 2017 03:10 AM Go to last post
130 737
SFDA regulations and other applicable regulations related to medical devices in China.
15th March 2017 01:31 PM Go to last post
75 418
The 3 Medical Device Directives and other applicable regulations related to Medical Devices in the EU (European Union).
28th April 2017 03:58 AM Go to last post
1,029 6,732
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
by Ronen E
28th April 2017 07:13 PM Go to last post
1,594 9,702
Regulatory systems around the world different from the ones in the above sub-forums.
28th April 2017 01:54 PM Go to last post
551 3,589
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.
28th April 2017 08:11 PM Go to last post
3,379 25,065
ISO 13485 - Medical Device Quality Management System Requirements for Regulatory Purposes - (ISO 14969 has been replaced by ISO 13485:2016).
28th April 2017 12:30 AM Go to last post
2,062 15,589
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.
28th April 2017 08:11 PM Go to last post
238 2,028
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.
25th April 2017 08:24 AM Go to last post
636 4,207
IEC 62304 - Requirements for a development life cycle of medical device software, including medical device software risk management.
19th April 2017 01:05 PM Go to last post
142 1,136
Application of usability (human factors engineering) engineering to medical devices.
by mvroops
4th April 2017 03:50 AM Go to last post
36 388
Medical Device Related Standards not listed in the above sub-forums.
28th April 2017 02:25 AM Go to last post
265 1,717
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 Ronen E
28th April 2017 07:18 PM Go to last post
290 1,799

 
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