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Medical Devices, Medical Information Technology, Medical Software and Health Informatics
Medical Device Related Standards
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Biocompatibility - ISO 10993 and SVHC Requirements
Riskophil
Jul 22, 2016
Replies
4
Views
3K
Jun 24, 2019
Ronen E
GTIN (Global Trade Item Number) for non CE Mark
Ed Panek
Jun 21, 2019
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2K
Jun 24, 2019
pkost
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R
510(k) Biocompatibility vs Cleaning Validation
restis7
Jun 17, 2019
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4
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2K
Jun 20, 2019
indubioush
I
T
Colour of symbols on Medical Device labelling and packaging
TechnicalGuy
Jun 19, 2019
Replies
1
Views
3K
Jun 19, 2019
craiglab
C
S
Can we still manufacture whilst awaiting return of our CE Mark?
Shellk66
Jun 18, 2019
Replies
1
Views
908
Jun 18, 2019
craiglab
C
F
Class I Device under MDD, reclassified to Class II under MDR
Frypot
Jun 17, 2019
Replies
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Jun 17, 2019
Frypot
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C
Deviation in Design verification
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Views
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Jun 14, 2019
indubioush
I
Cleanroom Monitoring Plan - ISO14644-2:2015 - Risk Assessment
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Apr 29, 2019
Replies
3
Views
2K
Jun 14, 2019
indubioush
I
P
ISO 80369-7 standard - Interpreting which Parts should be in scope
player64
Jun 5, 2019
Replies
7
Views
2K
Jun 6, 2019
player64
P
Q
UDI and Standalone Software - UDI per installation?
qmvpma
Dec 15, 2014
Replies
6
Views
4K
May 30, 2019
RL-WANG
R
D
What is your Sterile Medical Device Pouch Peel Strength Spec?
d.conroy
Sep 15, 2018
Replies
3
Views
3K
May 28, 2019
frank
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Technical File Reviewer has requested more testing to ISO 10993
Norcofox
May 23, 2019
2
Replies
10
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3K
May 24, 2019
Ronen E
FDA and Biocompatability Testing - Reviewer has requested implantation testing
lilybef
Jan 23, 2019
2
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11
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May 1, 2019
lilybef
K
Bioburden 0 cfu for Dose Setting using the VDmax25
Kees Fremerij
Nov 30, 2016
Replies
9
Views
4K
Apr 17, 2019
Kees Fremerij
K
L
Digitalization of documents - FDA and ISO 13485
LauraH
Apr 9, 2019
Replies
1
Views
1K
Apr 9, 2019
Ronen E
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