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ISO 13485 - Medical Device Quality Management System Requirements for Regulatory Purposes - (ISO 14969 has been replaced by ISO 13485:2016).
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Recovery Plan for Unmet Quality Objectives
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7
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209
TabithaL96
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100% verification. Is validation necessary?
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4
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293
Ed Panek
Ed Panek
Renea Koski QAM
How do I issue/word a CAR for a past employee's failures?
2 3
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20
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858
normzone
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Anaesthetic Vaporizers
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0
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92
Vaporizer3
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Electronic QMS Documentation
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2
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232
bimeri
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Identifying GAMP Classification: GAMP 4 or GAMP 5
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2
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v9991
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MrTetris
Packaging specifications for sterile and non-sterile medical devices
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3
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343
FRA 2 FDA
FRA 2 FDA
Ed Panek
Received Material on Hold
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2
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161
Ron Rompen
Ron Rompen
QCBOB
New to ISO 13485, any suggestions?
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6
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382
FRA 2 FDA
FRA 2 FDA
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Attachment in a document to be release as reference
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4
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231
Tidge
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Talja
Is there any requirement to be compliant with IEC 62304 while implementing ISO 13485
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11
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yodon
Y
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Purchasing Process for paper IFU Printing Company
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2
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139
ScottK
ScottK
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ISO 13485:2016 Internal Audits method
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18
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QCBOB
QCBOB
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Semi-automation in software for implant design
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3
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120
yodon
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Melissa
CAR is not good enough! Operator Error!
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49
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7K
Johnnymo62
Johnnymo62
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