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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ISO 13485 - Medical Device Quality Management System Requirements for Regulatory Purposes - (ISO 14969 has been replaced by ISO 13485:2016).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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Design Transfer of medical device
Milas
Apr 2, 2024
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314
Yesterday at 1:48 PM
yodon
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Certification Scope
H.Richardson
Wednesday at 12:53 PM
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Wednesday at 6:33 PM
indubioush
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EN 13485 - point 4.1.6 vs 7.5.6
lennsy
Tuesday at 7:19 AM
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Tuesday at 11:22 AM
shimonv
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Mixed OEM CE IVDs sold in a Kit
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Tuesday at 10:11 AM
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Tuesday at 10:11 AM
Mogget
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Clause 7.6 for design and development
SamKD
Jun 30, 2023
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Tuesday at 9:09 AM
Ed Panek
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Recovery Plan for Unmet Quality Objectives
TabithaL96
Apr 11, 2024
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Apr 12, 2024
TabithaL96
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ISO Certification Scope Requirements
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Apr 11, 2024
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Apr 11, 2024
djc4388
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The path from nonconformity - design change to CAPA
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Apr 11, 2024
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Apr 11, 2024
bimeri
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100% verification. Is validation necessary?
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Apr 8, 2024
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Apr 10, 2024
Ed Panek
How do I issue/word a CAR for a past employee's failures?
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Apr 3, 2024
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Apr 9, 2024
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Apr 8, 2024
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Feb 24, 2022
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Apr 7, 2024
v9991
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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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Apr 5, 2024
qualitynewbie
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Validation process
KarenA01
Apr 5, 2024
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Apr 5, 2024
KarenA01
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