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ISO 13485 - Medical Device Quality Management System Requirements for Regulatory Purposes - (ISO 14969 has been replaced by ISO 13485:2016).
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Scope of Audit
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Chrisx
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ISO 14971 applicability in ISO 13485
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10
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1K
Chrisx
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M
Is it an onsite audit mandatory as part of ISO 13485 certification?
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13
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592
Ed Panek
Ed Panek
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Purchasing: Written agreement that the supplier will notify the organization of any changes to purchased product
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5
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335
contigo123
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N
Validation of Packaging of Non-Sterile Medical Devices
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17
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humoor
humoor
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QMS under the MDR
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1
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161
yodon
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N
Contract Manufacturing Acceptance Testing IQC Process
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3
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110
shimonv
shimonv
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Certification Scope
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4
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190
ChrisM
ChrisM
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ISO Certification Scope Requirements
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2
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241
Chrisx
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UDI for custom-made device
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0
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98
ttylda
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W
ISO 13485:2016 / MDSAP Surveillance 2 Audit Delay Consequences
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2
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173
Ed Panek
Ed Panek
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Design Transfer of medical device
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8
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433
yodon
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L
EN 13485 - point 4.1.6 vs 7.5.6
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3
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219
shimonv
shimonv
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Mixed OEM CE IVDs sold in a Kit
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0
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138
Mogget
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S
Clause 7.6 for design and development
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11
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714
Ed Panek
Ed Panek
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