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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ISO 13485 - Medical Device Quality Management System Requirements for Regulatory Purposes - (ISO 14969 has been replaced by ISO 13485:2016).
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ISO 13485 and Class 1 Medical Device - FDA thinking
markl368
Apr 23, 2014
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15
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20K
Feb 13, 2024
Eloisa0819
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Trusting ISO 13485 Certification of a Supplier... A Sad Story
MIREGMGR
Sep 8, 2011
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Jul 27, 2021
Sidney Vianna
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UDI (Unique Device Identification): HIBCC or GS1?
Edward Reesor
Jul 6, 2017
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Apr 16, 2021
RL-WANG
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ISO 13485 - Medical Device Quality Management System Standard
Marc
Apr 12, 2010
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Jun 9, 2020
DuncanGibbons
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ISO 13485:2015 Pre-Release News and Discussion
Marcelo
Apr 14, 2011
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Jun 18, 2015
Marcelo
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The US's FDA and other Medical Device Related Forums
Marc
Oct 18, 2009
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Oct 18, 2009
Marc
Discussions
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Purchasing Process for paper IFU Printing Company
bimeri
Yesterday at 10:34 AM
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2
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47
Yesterday at 11:55 AM
ScottK
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ISO 13485:2016 Internal Audits method
T.Garcia
Nov 28, 2023
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18
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919
Yesterday at 11:07 AM
QCBOB
Is there any requirement to be compliant with IEC 62304 while implementing ISO 13485
Talja
Dec 21, 2017
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9
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4K
Tuesday at 2:00 PM
Ed Panek
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Semi-automation in software for implant design
ttylda
Tuesday at 6:53 AM
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3
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54
Tuesday at 10:49 AM
yodon
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New to ISO 13485, any suggestions?
QCBOB
Sunday at 2:26 PM
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158
Monday at 7:39 PM
DannyK
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Documentation of Design changes
Mkm1989
Friday at 6:43 PM
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Monday at 12:24 PM
yodon
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CAR is not good enough! Operator Error!
Melissa
Aug 10, 2021
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Saturday at 10:25 AM
Johnnymo62
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Out of Spec CNC
TroyM
Mar 15, 2024
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195
Friday at 2:50 PM
TroyM
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13485 clause 7.5.6 (f) revalidation, including criteria for revalidation
W.Kaminski
Mar 21, 2024
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158
Friday at 1:00 PM
Tidge
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EQMS software for startup medical device company
qualitynewbie
Jan 17, 2024
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660
Mar 21, 2024
bimeri
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New revisions of controlled documents
laslo3001
Mar 19, 2024
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Mar 19, 2024
laslo3001
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Validation of Software regarding ISO 13485:2016
Denzel
Mar 7, 2024
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Mar 10, 2024
Denzel
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Revision Reset for documents and components
evan_kim90
Feb 28, 2024
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412
Mar 9, 2024
Enternationalist
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Supplier components
evan_kim90
Mar 8, 2024
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136
Mar 9, 2024
Enternationalist
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ISO 13485 - Control of Records (4.2.5) question
johnjflynn42
Feb 5, 2024
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10
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466
Mar 8, 2024
Tidge
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