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Medical Device and FDA Regulations and Standards News

Discussions
dgrainger
Informational EU published new Harmonised Standards List for the Directives (25/3/2020)
Replies
0
Views
81
dgrainger
F
The EU Drafts Bill to Postpone MDR by a Year (3/2020)
Replies
2
Views
81
Watchcat
F
Will the EU postpone 2017/745 MDR Implementation - COVID-19 Impact
Replies
6
Views
246
jham65
V
Manufacturing requirements for respiratory ventilators - clean room required?
Replies
6
Views
95
Al Rosen
M
Differences in post market safety reporting for Combination Product Applicants
Replies
1
Views
92
TorstenKn
K
Biocompatibility evaluation of gas pathways
Replies
5
Views
118
khann
R
Plea for advice on transitioning between Notified Bodies (label updates)
Replies
1
Views
101
Ronen E
K
Product (Device) Life cycle - Product Life AFTER the Post Market Phase
Replies
3
Views
80
KAPL61
M
Special Controls and Class II Medical Devices
2
Replies
17
Views
285
MikeKilkelly
M
Informational Creating a post market surveillance (PMS) system for medical devices – Part 1
Replies
7
Views
965
Ronen E
Watchcat
What's up with MDSAP lately?
Replies
2
Views
300
Watchcat
F
Is there such a thing as 'Critical supplier' status under the Dept. of Health (UK)?
Replies
2
Views
102
Frypot
S
FDA's E submitter - For clinical electronic thermometer
Replies
6
Views
119
Shawna
M
Post Market Surveillance for Class II Medical Devices
Replies
2
Views
152
MikeKilkelly
C
Is it required to put"Rx only" on the home page of an app?
Replies
4
Views
110
CoBult
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