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Medical Device and FDA Regulations and Standards News

Discussions
Q
Need clarification on requirements.... Class i, gmp & 510(k) exempt
Replies
2
Views
93
Ronen E
M
Informational USFDA – Review framework for artificial intelligence-based medical devices
Replies
1
Views
227
Jesse Shearin
M
Informational ISO 14971 / ISO TR 24971 revision update – atualizações sobre a revisão
Replies
1
Views
510
Sidney Vianna
G
Do we need to QA cert? We only plan to supply reagents
Replies
3
Views
202
Watchcat
M
Medical Device News EU – Transition Timelines from the Directives to the Regulations – Medical Devices and in vitro Diagnostic Medical Devices
2
Replies
13
Views
1,187
Ronen E
L
Global distributor vigilance responsibility
2
Replies
14
Views
413
Watchcat
K
Is a change that fixes a recalled device significant?
Replies
2
Views
194
dgrainger
D
Are we the manufacturer or relabeler?
Replies
2
Views
175
Ronen E
P
Predicate Device Information for 510(k) Submission
Replies
4
Views
235
Watchcat
M
User manual / instructions for use for class II device always required?
Replies
3
Views
197
Ronen E
M
Informational EU – Official position on EUDAMED delay
Replies
3
Views
399
Nuno_
M
Informational ISO 13485:2016 under systematic review
Replies
5
Views
524
Ronen E
L
Significant change notice for outsourced warehouse
Replies
2
Views
164
craiglab
M
Medical device country of origin
Replies
5
Views
176
MariaHj
M
Informational TGA – Submissions received: Regulation of software, including Software as a Medical Device (SaMD)
Replies
1
Views
189
Ronen E
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