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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
266
Posts
1.3K
Threads
266
Posts
1.3K
E
MDEL renewal
May 1, 2024
EmiliaBedelia
China Medical Device Regulations
SFDA regulations and other applicable regulations related to medical devices in China.
Threads
128
Posts
656
Threads
128
Posts
656
D
Returning Overseas Implantable Complaint Product to China
Feb 29, 2024
Daniel Zhang
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
15.7K
Threads
2.7K
Posts
15.7K
MDR Clinical Evaluation Plan
Yesterday at 9:24 AM
Ed Panek
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
80
Posts
338
Threads
80
Posts
338
D
Qualification of Medical Transcription Software
May 3, 2024
DanMann
US Medical Device Regulations
United States Medical Device Regulations
Threads
2.4K
Posts
13.6K
Sub-forums:
21 CFR Part 820 - US FDA Quality System Regulations (QSR)
Other US Medical Device Regulations
Threads
2.4K
Posts
13.6K
B
Animal Devices - Some Questions
Thursday at 5:00 PM
B_Cologne
Other Medical Device Regulations World-Wide
Regulatory systems around the world different from the ones in the above sub-forums.
Threads
886
Posts
5.1K
Threads
886
Posts
5.1K
B
Russia, authority representative medical device
Apr 29, 2024
Belen Sanchez
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Ear, nose, and throat E.N.T devices
nizark
Mar 27, 2023
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2K
Mar 27, 2023
nizark
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M
MAUDE Report
margadia
Mar 4, 2022
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4
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3K
Mar 8, 2022
margadia
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Transport of components off site for final assembly.
regi_601
Jan 21, 2022
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2
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1K
Jan 21, 2022
regi_601
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A
Add MDSAP to Internal Audit Schedule
AADIVISH
Apr 5, 2021
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0
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2K
Apr 5, 2021
AADIVISH
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J
Requirements as a Distributor for Incoming Inspection of Purchased Finished Medical Device
jdlin47
Mar 22, 2021
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Mar 22, 2021
jdlin47
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