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Medical Devices, Medical Information Technology, Medical Software and Health Informatics
Medical Device Related Regulations
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US Medical Device Regulations
United States Medical Device Regulations
21 CFR Part 820 - US FDA Quality System Regulations (QSR)
21 CFR (Code of Federal Regulations) Part 820 related discussions.
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How do I show compliance to 21CFR820?
Nov 17, 2023
Ed Panek
Other US Medical Device Regulations
Other applicable regulations and topics related to United States medical devices and manufacturers.
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Operators Manual update to product in the field
Nov 3, 2023
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FDA premarket Inspection
Regsblue
Nov 23, 2023
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0
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106
Nov 23, 2023
Regsblue
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Making a profit from running a clinical trial
shimonv
Nov 22, 2023
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3
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87
Nov 23, 2023
shimonv
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Determination of Production Equivalence for V&V and Pivotal Clinical Trials
EvRi1
Nov 21, 2023
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118
Nov 22, 2023
EvRi1
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Labelling of convenience Kit
LAM2020
Nov 21, 2023
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60
Nov 21, 2023
LAM2020
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Regulatory Path for Providing Sterile Product in Bulk Non-Sterile Form to Kit Packers
Leigh76
Apr 6, 2023
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363
Nov 21, 2023
LAM2020
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MDDS: What type of control/parameter change makes it a medical device?
SSchoepel
Nov 3, 2023
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191
Nov 14, 2023
Tidge
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MAUDE Database nonsense
Ed Panek
Oct 4, 2023
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3
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321
Nov 13, 2023
Tidge
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FDA Cybersecurity risk assessment
summer
Nov 11, 2023
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2
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149
Nov 13, 2023
summer
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Serial Number labelling - Medical Devices
stm55
Nov 3, 2023
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4
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155
Nov 10, 2023
yodon
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FDA Inspections
dj123
Nov 2, 2023
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1
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131
Nov 2, 2023
yodon
Y
Design Verification Bench Test Requirements
DLesterB
Sep 25, 2023
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298
Oct 17, 2023
DLesterB
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Not made with natural rubber latex and not made with DEHP symbol
destroyed9218
Oct 11, 2023
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194
Oct 16, 2023
destroyed9218
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How to search the granted Breakthrough Devices in FDA
Mandy0528
Oct 11, 2023
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Oct 11, 2023
Mandy0528
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820.90 Nonconforming product - Rework
Tom Penn
Sep 20, 2023
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324
Oct 9, 2023
Tom Penn
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UDI on reprocessed device (US only)
destroyed9218
Oct 6, 2023
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175
Oct 6, 2023
EmiliaBedelia
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Medical Device Related Regulations
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