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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ISO 13485 - Medical Device Quality Management System Requirements for Regulatory Purposes - (ISO 14969 has been replaced by ISO 13485:2016).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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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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QMS under the MDR
iam1235
Apr 26, 2024
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Thursday at 10:45 AM
yodon
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Validation of Packaging of Non-Sterile Medical Devices
Noha Ahmed
Sep 23, 2023
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Wednesday at 3:47 PM
EmiliaBedelia
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Contract Manufacturing Acceptance Testing IQC Process
NJSAMZN
Tuesday at 11:26 PM
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Wednesday at 2:01 PM
shimonv
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ISO 13485 Internal Audit
Andrada T.
Apr 24, 2024
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444
Monday at 2:24 AM
Andrada T.
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Validation process
KarenA01
Apr 5, 2024
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Apr 26, 2024
v9991
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The path from nonconformity - design change to CAPA
bimeri
Apr 11, 2024
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Apr 24, 2024
toniriazor
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Certification Scope
H.Richardson
Apr 17, 2024
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Apr 23, 2024
ChrisM
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ISO Certification Scope Requirements
djc4388
Apr 11, 2024
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Apr 23, 2024
Chrisx
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UDI for custom-made device
ttylda
Apr 23, 2024
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Apr 23, 2024
ttylda
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ISO 13485:2016 / MDSAP Surveillance 2 Audit Delay Consequences
Whirlyball
Apr 19, 2024
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Apr 22, 2024
Ed Panek
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Design Transfer of medical device
Milas
Apr 2, 2024
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Apr 18, 2024
yodon
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EN 13485 - point 4.1.6 vs 7.5.6
lennsy
Apr 16, 2024
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Apr 16, 2024
shimonv
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Mixed OEM CE IVDs sold in a Kit
Mogget
Apr 16, 2024
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Apr 16, 2024
Mogget
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Clause 7.6 for design and development
SamKD
Jun 30, 2023
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Apr 16, 2024
Ed Panek
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Recovery Plan for Unmet Quality Objectives
TabithaL96
Apr 11, 2024
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192
Apr 12, 2024
TabithaL96
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