2020 - Fundamentals of EU MDR and IVDR – Level 1

Objectives of the medical device regulation
Directives replaced with regulation
Risk based device classification
Conformity assessment and its relevant changes (Annex IX, Annex X, Annex XI)
Requirements for technical documentation found in GSPR Annex 1
UDI and traceability requirements, responsibilities, and impacts (EUDAMED)
Process for clinical evaluations
Clinical evidence with supported documentation
Post market requirements (Annex XIV and Annex 3 Part B)
Audit management and Notified Bodies requirements for manufacturers, as well as internal audit impact (Article 51, Annex V111)
Impact on the Quality Management System