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Medical Devices, Medical Information Technology, Medical Software and Health Informatics
Medical Device Related Standards
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C
Quarterly dose audit and date of manufacture
Chrisx
Dec 21, 2023
Replies
1
Views
223
Dec 22, 2023
chris1price
C
ISO 14708-5 Implants for surgery - AIMD_ Clause 6.3.1 Evidence Mapping
cobedangthuong
Dec 19, 2023
Replies
0
Views
187
Dec 19, 2023
cobedangthuong
C
M
Testing with accredited Laboratory
Manel Mou
Nov 22, 2023
Replies
8
Views
403
Nov 28, 2023
dwperron
D
N
Biocomp / bioburden for new MFR
nealster75
Nov 17, 2023
Replies
1
Views
256
Nov 19, 2023
planB
J
Labelling and Packaging
Jes890
Nov 17, 2023
Replies
0
Views
325
Nov 17, 2023
Jes890
J
M
ISO/IEEE 11073 standards
mwaller
Nov 15, 2023
Replies
1
Views
176
Nov 16, 2023
Hi_Its_Matt
H
M
Abbott IFU's no longer available to non-customers, anyone have a resource?
Mike W
Nov 13, 2023
Replies
0
Views
230
Nov 13, 2023
Mike W
M
T
Custom-made MD - Cleaning&Sterilization Validation
ttylda
Nov 6, 2023
Replies
4
Views
229
Nov 10, 2023
ttylda
T
S
ISO 11607-1:2019
StepPCHen
Oct 27, 2023
Replies
3
Views
427
Oct 30, 2023
StepPCHen
S
K
SFDA now asks for "Certification to ISO 10993-1" for class III device?
kabemu
Oct 12, 2023
Replies
2
Views
330
Oct 23, 2023
kabemu
K
K
Quality Agreement MDR - The manufacturer is outside of EU
Kasia
Feb 5, 2021
Replies
6
Views
3K
Oct 23, 2023
DanMann
D
N
Product family determination (Gamma)
NavTo
Oct 18, 2023
Replies
1
Views
203
Oct 18, 2023
planB
A
EU GMP
AQARA
Oct 9, 2023
Replies
9
Views
401
Oct 10, 2023
SeanN
S
B
How to integrate risk assessment of a medical device to a SOP for ISO 14155:2020
bill.Kal
Sep 19, 2023
Replies
1
Views
345
Oct 6, 2023
Enternationalist
O
Maximum Force for Crushing Hazard?
OccamMan
Aug 29, 2023
Replies
4
Views
492
Sep 19, 2023
OccamMan
O
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