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course med DNV Business Assurance
Kursus
13.600,00 DKK
612,00 DKK
I alt ekskl. moms
14.212,00 DKK
25% moms
3.553,00 DKK
I alt inkl. moms
17.765,00 DKK
About MDSAP - MEDICAL DEVICE SINGLE AUDIT PROGRAM Why this course: This course pack is designed to give you a detailed understanding of the medical device single audit program. After the training you will have a good knowledge of the MDSAP regulatory requirements, skills to implement the requirements within your organisation and an increased readiness to host a MDSAP audit. Who can attend this course: - Quality Managers - Regulatory Affairs personnel - Internal Auditors Pre-requisites: For successful completion of this course, it is expected that you have prior knowledge of ISO 13485:2016 standard. It is also recommended to have prior knowledge of the Regulatory Registration with the following countries: - FDA – US - ANVISA – Brazil - HC – Canada - TGA – Australia - PMDA – Japan Language: The training is in English. Course highlights: - An overview of the MDSAP - Focus on key Processes - How to use the MDSAP Audit Model and its tools Course objectives:At the end of this training session, you will have a very good understanding of: - The requirements as stated in the MDSAP and - The benefits of enrolling into the MDSAP Program Venue: The training is held as online training.
Foredragsholder: DNV Business Assurance
Varighed: minutter
Sprog: Dansk
Tilgængelighed:
Tilgængelig fysisk
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