To obtain the MDSAP certification, should we have both ISO 13485 AND 9001, or just ISO 13485?
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ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more 
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
Expert
Strahinja Stojanovic
May 14, 2018
Dear Alice,
MDSAP program basically uses ISO 13485:2003 as a framework, in addition to good manufacturing practice (GMP) requirements of the various regulatory authorities. Auditors follow a structured and logical process approach, with links to other processes; this is all clearly explained in the medical device application profile (MDAP) audit model and the MDSAP Companion Document.
You can use parts of ISO 13485 to cover the requirements of MDSAP, but the standard itself is not required to achieve MDSAP certification.
MDSAP program basically uses ISO 13485:2003 as a framework, in addition to good manufacturing practice (GMP) requirements of the various regulatory authorities. Auditors follow a structured and logical process approach, with links to other processes; this is all clearly explained in the medical device application profile (MDAP) audit model and the MDSAP Companion Document.
You can use parts of ISO 13485 to cover the requirements of MDSAP, but the standard itself is not required to achieve MDSAP certification.
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May 12, 2018
May 14, 2018
May 14, 2018