Medical Device and FDA Regulations and Standards News

Discussions
G
Declare interoperability in a 510K
Replies
0
Views
51
Galac
A
EO Residual for Sterilization of Implantable Products
Replies
6
Views
140
akyt
A
Medical Device Software POC
Replies
6
Views
198
Junn1992
B
Re-use of ETO Sterilized products
Replies
6
Views
234
monoj mon
K
Do Contract Manufacturers need a complaint procedure?
2
Replies
10
Views
1,008
abublitz
E
DESIGN VALIDATION, USABILITY AND CLINICAL EVALUATION request
Replies
0
Views
143
Elisa Carloni
A
Applying agile model for Computer system Validation
Replies
3
Views
307
Shreya Gautam
I
What are suitable indicators and threshold values in MDR/IVDR?
Replies
5
Views
353
Steve Prevette
A
ISO 20417:2021 Country of Manufacture
Replies
2
Views
620
ASteel
A
Legacy Devices
Replies
1
Views
171
TorstenKn
M
Informational EU – Official position on EUDAMED delay
Replies
9
Views
1,531
Raisin picker
S
Country of Manufacturer
Replies
0
Views
132
sallyann
B
Documenting Medical Device Complaints after End of Life?
Replies
0
Views
176
Bill Briley
M
Surgical angle measurement guide device with an application software
Replies
4
Views
573
lucasEthosMed
I
Release checklist EO sterilization process
Replies
8
Views
1,041
planB
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