Other Medical Device Related Standards

Medical Device Related Standards not listed in the above sub-forums.
FAQs
M
  • Sticky
Informational Links to recognized / harmonised / consensus Standards for each market
Replies
5
Views
522
Ellison
Sam Lazzara
  • Sticky
February 2013 Medical Device "State-of-the-Art" updates
Replies
6
Views
5,263
Ronen E
Marc
  • Sticky
Medical Device Standards - Difference between IEC and EN Standards
2
Replies
13
Views
19,680
rob73
Discussions
P
Finding UMDNS (Universal Medical Device Nomenclature System) Codes
Replies
6
Views
21,259
surawuth
S
ISO 10993 Biocompatibility Evaluation - Electronic thermometer
Replies
1
Views
109
yodon
shrutisancheti
Predicate device accelerated aging - 1 year of shelf life is already over
Replies
0
Views
90
shrutisancheti
Marcelo Antunes
ISO TR 20416 Medical Devices - Post-Market Surveillance for Manufacturers
Replies
3
Views
2,534
Sam Lazzara
P
ISO 10993-1:2018 - When will the European equivalent become a Harmonized Standard?
Replies
6
Views
132
Ronen E
A
Device Classification - India CDCSO - How to classify the device?
Replies
1
Views
114
anbknaga
M
FDA Guidance - general wellness products - wearables
Replies
2
Views
290
Gish Consulting
N
Regulatory Affairs Certificate (Medical Device and Pharmaceuticals
Replies
7
Views
3,888
irisolve
I
ISO 10993 Biocompatibility Requirements - manufacturing process chemicals
Replies
8
Views
336
Ronen E
R
Biocompatibility - ISO 10993 and SVHC Requirements
Replies
4
Views
1,613
Ronen E
TechnicalGuy
Colour of symbols on Medical Device labelling and packaging
Replies
1
Views
123
craiglab
F
Class I Device under MDD, reclassified to Class II under MDR
Replies
5
Views
154
Frypot
chris1price
Cleanroom Monitoring Plan - ISO14644-2:2015 - Risk Assessment
Replies
3
Views
293
indubioush
Q
UDI and Standalone Software - UDI per installation?
Replies
6
Views
2,341
RL-WANG
D
What is your Sterile Medical Device Pouch Peel Strength Spec?
Replies
3
Views
598
frank
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