What content is taught in the seminar?
- The four levels of statutory and normative regulation at international, EU and national level
- An insight into the evolution of standards and the background to harmonized standards
- The documentation of the medical device cycle in different jurisdictions (USA, EU, STED) and their documentation structures (MDR, ISO 13486, FDA, GHTF)
- The most important annexes of the MDR (I, II, III, XV, XIV) with a focus on the rights and obligations of the persons involved after placing on the market
- An excursus on the scope of the MDR, its assessment procedures and products without an intended medical purpose
- The rules for sampling and the topics to be audited