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Medical Device Related Standards

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.


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Links that Cove visitors will find useful in your quest for knowledge:

International Standards Bodies - World Wide Standards Bodies

ASQ - American Society for Quality

International Standards Organization - ISO Standards and Information

Howard's
International Quality Services


Marcelo Antunes'
SQR Consulting, and
Medical Devices Expert Forum


Bob Doering
Bob Doering's Blogs and,
Correct SPC - Precision Machining


Ajit Basrur
Claritas Consulting, LLC


NIST's Engineering Statistics Handbook

IRCA - International Register of Certified Auditors

SAE - Society of Automotive Engineers

Quality Digest

IEST - Institute of Environmental Sciences and Technology

Medical Device Related Standards - Sub-Forum(s) Search this Forum
  Forum Last Post or Poll Vote Threads Posts
ISO 13485 - Medical Device Quality Management System Requirements for Regulatory Purposes - (ISO 14969 has been replaced by ISO 13485:2016).
9th December 2016 06:22 PM Go to last post
2,030 15,329
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.
11th November 2016 01:50 PM Go to last post
224 1,878
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.
7th December 2016 07:00 AM Go to last post
616 4,109
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 Sheemah
1st November 2016 12:43 PM Go to last post
33 372
Medical Device Related Standards not listed in the above sub-forums.
5th December 2016 02:35 AM Go to last post
259 1,674

 
Medical Device Related Standards - Discussion Threads Forum Tools Search this Forum
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