Medical Device and FDA Regulations and Standards News

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Requirements for "Claims Guide" for medical devices
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6
Views
370
SGquality
M
Informational US FDA Final and update guidances – Software
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2
Views
327
duinyk
C
FDA Establishment registration - Buying some medical devices from another manufacturer
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5
Views
353
monoj mon
M
Special Controls and Class II Medical Devices
2
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18
Views
704
duinyk
dinakim_zv
IDE sponsor and investigator
Replies
5
Views
119
monoj mon
dgrainger
Informational EU medical device website change from 'Growth' to 'Health and Food Safety' (6/2020)
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0
Views
130
dgrainger
M
Informational RoHS Standard - EN 63000:2018 to replace EN 50581:2012
2
Replies
11
Views
585
CharlieUK
I
Release checklist EO sterilization process
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3
Views
234
planB
H
Queries: RFD & Pre-RFD Program
Replies
0
Views
178
Heena Thakkar
P
Establishment Registration and Device listing - Wording of 807.20 (a) (6)
Replies
3
Views
532
Heena Thakkar
Y
Expanding the indications for use for a 510(k) cleared device
Replies
5
Views
330
Heena Thakkar
F
Will the EU postpone 2017/745 MDR Implementation - COVID-19 Impact
2
Replies
11
Views
974
fialor
dgrainger
Informational Parliament to vote on postponing new requirements for medical devices -17th April
Replies
1
Views
21,546
dgrainger
M
PPE shelf life
Replies
1
Views
318
Jim Wynne
dgrainger
Informational Postponement of MDR - adopted by the Commission - April 2020
Replies
3
Views
423
dgrainger
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