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Kursus med DNV Business Assurance
Design Control for Medical Devices
Pris pr. deltager
Kursus
6.800,00 DKK
306,00 DKK
I alt ekskl. moms
7.106,00 DKK
25% moms
1.776,50 DKK
I alt inkl. moms
8.882,50 DKK
Se tilgængelighed
About Design Control/ Design and Development and its process interfaces What will you learn: You will get knowledge of the Design Control/Design and Development process in detail and how to use the interface to other processes in an effective way. Program: - Product realization planning - Design input - Design output - Traceability matrix - Design verification - Design validation - Design transfer - Design changes - Design History File/Design and Development File - MDSAP audit technique - Risk Management ISO 14971:2019 interface - Usability Engineering ISO/IEC 62366-1:2015 interface - Post Market Surveillance MDR/IVDR interface - The processes interface flow chart Course Leader: Anette Sjögren, PREVENTIA AB Anette is a member of the Swedish (TK355 – ISO 13485, ISO 14971 and IEC 62366) and the international technical (TC210) committee and was also part of the international PMS task force. Language: Course material is in English. Presentation in English or Swedish (depending on the participants).
Foredragsholder: DNV Business Assurance
Varighed: minutter
Sprog: Dansk
Tilgængelighed:
Tilgængelig fysisk
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