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Medical Devices, Medical Information Technology, Medical Software and Health Informatics
Medical Device Related Standards
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ISO 13485:2016 - Medical Device Quality Management Systems
ISO 13485 - Medical Device Quality Management System Requirements for Regulatory Purposes - (ISO 14969 has been replaced by ISO 13485:2016).
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Technical & Risk Management File - Subcontract manufacturer
SilverHawk
Dec 16, 2004
Replies
4
Views
2,738
Dec 17, 2004
johnquinn
A
Device Serialization - Generating a unique identifying serial number
antho10359
Dec 8, 2004
Replies
1
Views
2,552
Dec 8, 2004
lindal
V
ISO/CD 14969 - Draft of the Guidelines to Implement ISO 14385:2003
Vincnet
Oct 22, 2003
Replies
4
Views
5,640
Dec 6, 2004
evans_o
A
Audit of medical device company with prototype of product
Asherlee
Dec 6, 2004
Replies
2
Views
2,353
Dec 6, 2004
Asherlee
S
How do you control your clinical documents, like surveys, consents, authorizations?
sardonyx
Nov 24, 2004
2
Replies
18
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6,551
Dec 1, 2004
lindal
W
Japanese Market - Any special requirements (regulatory or quality)?
wynyards - 2008
Nov 29, 2004
Replies
3
Views
2,344
Nov 30, 2004
Bridget
V
ISO 13485 - 8.2.1, 8.4, 8.5, and 8.5.2/3 - Specific Procedures Needed?
Viki N.
Oct 18, 2004
Replies
6
Views
5,370
Nov 30, 2004
wrodnigg
G
The most effective way to integrate CMDCAS requirements into Quality Manual
gjhaddock
Nov 3, 2004
Replies
4
Views
3,569
Nov 17, 2004
Bridget
K
Implant Contamination - 17-4 SS Devices - Machine Shop
Katydid
Oct 12, 2004
Replies
3
Views
3,038
Nov 4, 2004
Katydid
C
Medical Device: QSR and Clinical Trials and Design Controls
compliance - 2006
Oct 25, 2004
Replies
3
Views
3,026
Oct 28, 2004
compliance - 2006
S
Marketing Requirements vs Product Specifications
sardonyx
Oct 21, 2004
2
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14
Views
4,379
Oct 25, 2004
sardonyx
R
What is the transition deadline for ISO 13485:2003?
rick melton - 2007
Oct 18, 2004
Replies
4
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2,855
Oct 19, 2004
Al Rosen
C
Raw Materials verification - Melt Flow Test - Resins: Customer not Satisfied
Carl Keller
Oct 4, 2004
Replies
4
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3,069
Oct 5, 2004
Carl Keller
P
ISO 13485 : 2003 - When must the transition be completed in Japan?
Paul22
Sep 22, 2004
Replies
4
Views
2,963
Sep 23, 2004
Laurie Anderson
C
ISO 13485 - why keep 9001 registration
Carl Keller
Sep 21, 2004
2
Replies
15
Views
3,338
Sep 21, 2004
Laurie Anderson
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Medical Device Related Standards
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