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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ISO 13485 - Medical Device Quality Management System Requirements for Regulatory Purposes - (ISO 14969 has been replaced by ISO 13485:2016).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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Will auditing be replaced by AI?
d_addams
Yesterday at 3:12 PM
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3
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50
Yesterday at 6:52 PM
LUFAN
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Design Input - DHF
nehalmahajan55
Tuesday at 6:29 AM
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166
Yesterday at 9:18 AM
austin_howell
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Batch production requirements
Vignesh M
Tuesday at 1:55 AM
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89
Tuesday at 11:14 AM
shimonv
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Manufacturer in ISO 13485
Vignesh M
Tuesday at 7:36 AM
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90
Tuesday at 10:35 AM
yodon
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The path from nonconformity - design change to CAPA
bimeri
Apr 11, 2024
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5
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290
Monday at 10:48 AM
toniriazor
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ISO 13485:2016 Internal Audit checklist/template?????
QCBOB
Monday at 8:10 AM
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89
Monday at 9:12 AM
shimonv
Design Output
nehalmahajan55
Saturday at 1:23 AM
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145
Monday at 9:07 AM
Ed Panek
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ISO 13485 Internal Audit
Andrada T.
Apr 24, 2024
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May 9, 2024
LUFAN
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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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293
May 8, 2024
Chrisx
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Scope of Audit
Vignesh M
May 8, 2024
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May 8, 2024
Chrisx
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ISO 14971 applicability in ISO 13485
DarisS
May 6, 2021
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1K
May 8, 2024
Chrisx
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Is it an onsite audit mandatory as part of ISO 13485 certification?
Mangafanga
Nov 17, 2023
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576
May 7, 2024
Ed Panek
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Purchasing: Written agreement that the supplier will notify the organization of any changes to purchased product
qualitynewbie
Apr 1, 2024
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319
May 6, 2024
contigo123
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Validation of Packaging of Non-Sterile Medical Devices
Noha Ahmed
Sep 23, 2023
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May 5, 2024
humoor
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