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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ISO 13485 - Medical Device Quality Management System Requirements for Regulatory Purposes - (ISO 14969 has been replaced by ISO 13485:2016).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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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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Identification of Products and Materials (obtaining sub components from over seas manufacturers)
R Walsh
Yesterday at 6:30 PM
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Yesterday at 6:30 PM
R Walsh
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Partially effective CAPA
Chrisx
Monday at 1:19 PM
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180
Wednesday at 9:03 PM
Jen Kirley
Design Input - DHF
nehalmahajan55
May 14, 2024
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253
Wednesday at 4:01 PM
EmiliaBedelia
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7.6 Control of Monitoring and Measuring Equipment
R Walsh
Wednesday at 1:50 PM
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Wednesday at 3:34 PM
Miner
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ISO 13485 Internal Audit
Andrada T.
Apr 24, 2024
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668
Tuesday at 6:40 AM
Guarina
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Documentation of Design changes
Mkm1989
Mar 22, 2024
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Tuesday at 3:45 AM
nehalmahajan55
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Equipment list
evan_kim90
May 17, 2024
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May 17, 2024
shimonv
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Will auditing be replaced by AI?
d_addams
May 16, 2024
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May 16, 2024
LUFAN
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Batch production requirements
Vignesh M
May 14, 2024
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May 14, 2024
shimonv
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Manufacturer in ISO 13485
Vignesh M
May 14, 2024
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104
May 14, 2024
yodon
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The path from nonconformity - design change to CAPA
bimeri
Apr 11, 2024
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305
May 13, 2024
toniriazor
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ISO 13485:2016 Internal Audit checklist/template?????
QCBOB
May 13, 2024
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150
May 13, 2024
shimonv
Design Output
nehalmahajan55
May 11, 2024
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159
May 13, 2024
Ed Panek
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Spin out company from existing ISO 13485 cert company
Kiranivd
May 9, 2024
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May 9, 2024
Kiranivd
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Validation process
KarenA01
Apr 5, 2024
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315
May 8, 2024
Chrisx
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