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Medical Devices, Medical Information Technology, Medical Software and Health Informatics
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Medical Device Related Regulations
Medical device regulations around the world. Regulations are laws set by a regulatory authority of a country or region and are generally mandatory.
Canada Medical Device Regulations
This forum is for Health Canada regulations and other applicable regulations related to medical devices in Canada.
Threads
277
Posts
1.4K
Threads
277
Posts
1.4K
Y
Medical Device Misclassified by Health Canada
Oct 27, 2024
yadwin2
China Medical Device Regulations
SFDA regulations and other applicable regulations related to medical devices in China.
Threads
130
Posts
663
Threads
130
Posts
663
How to display electronic data when audit by officer
Oct 12, 2024
Jen Kirley
EU Medical Device Regulations
The 3 Medical Device Directives and other applicable regulations related to Medical Devices in the EU (European Union).
Threads
2.7K
Posts
16.1K
Threads
2.7K
Posts
16.1K
MDR Classification Rule 10
Yesterday at 3:43 AM
WAQAR-QMS
Japan Medical Device Regulations
MHLW and PMDA regulations and other applicable regulations related to medical devices in Japan.
Threads
102
Posts
436
Threads
102
Posts
436
M
Does my "new" assay require a clinical study? or will a reference interval study suffice?
Mar 21, 2024
Mike W
UK Medical Device Regulations
UK Medical Device Regulations, especially with respect to BREXIT issues.
Threads
83
Posts
347
Threads
83
Posts
347
Draft PMS requirements for UK
Oct 21, 2024
dgrainger
US Medical Device Regulations
United States Medical Device Regulations
Threads
2.4K
Posts
13.8K
Sub-forums:
21 CFR Part 820 - US FDA Quality System Regulations (QSR)
Other US Medical Device Regulations
Threads
2.4K
Posts
13.8K
R
EMC requirements for IVD laboratory equipment
Yesterday at 1:41 AM
Robert_D
Other Medical Device Regulations World-Wide
Regulatory systems around the world different from the ones in the above sub-forums.
Threads
898
Posts
5.2K
Threads
898
Posts
5.2K
Do I need to report to ANVISA if my company name changes?
Thursday at 3:22 PM
kys123
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Ear, nose, and throat E.N.T devices
nizark
Mar 27, 2023
Replies
0
Views
3K
Mar 27, 2023
nizark
N
M
MAUDE Report
margadia
Mar 4, 2022
Replies
4
Views
3K
Mar 8, 2022
margadia
M
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Transport of components off site for final assembly.
regi_601
Jan 21, 2022
Replies
2
Views
2K
Jan 21, 2022
regi_601
R
A
Add MDSAP to Internal Audit Schedule
AADIVISH
Apr 5, 2021
Replies
0
Views
2K
Apr 5, 2021
AADIVISH
A
J
Requirements as a Distributor for Incoming Inspection of Purchased Finished Medical Device
jdlin47
Mar 22, 2021
Replies
0
Views
2K
Mar 22, 2021
jdlin47
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