Medical Device and FDA Regulations and Standards News

Discussions
B
  • Poll
Regulatory Affairs Certification (RAC) Book - Fundamentals of Medical Device Regulations
Replies
0
Views
30
BIORA
M
Test method validation - Is MSA (MSA1, MSA2, MSA3 and linearity) a good solution?
Replies
2
Views
924
tausReg
L
Change Notification Requirements for class 1 devices
Replies
1
Views
98
Lemko
D
Calibration tolerance question using Pipettes
Replies
3
Views
329
duff999
R
X-RAY Based Diagnostic Veterinary medical Devices
Replies
2
Views
161
Regulatory
F
Is USB-IF standard compliant with ISO13485?
Replies
3
Views
176
yodon
K
Relevant to ISO11135:2014
Replies
5
Views
174
komal bhavsar
A
Is there a standard on tolerances of substances ?
Replies
1
Views
150
planB
U
  • Locked
Is there any website out there that summarizes all relevant standards?
Replies
1
Views
221
Howard Atkins
E
  • Redirect
MDR internal audit
Replies
–
Views
–
N/A
D
Supplier audit
Replies
2
Views
357
dasadee
W
States that require service provider to have state license
Replies
0
Views
171
westindian
S
Need help on "Country of Origin"
Replies
0
Views
172
SGquality
M
Spain Notified Body
Replies
0
Views
142
marie luis murray
S
Transitional Adolescent A and B - "CDRH PREMARKET REVIEW SUBMISSION COVER SHEET FORM FDA 3514"
Replies
1
Views
394
planB
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