The request and requirements on clinical evaluations has increased over the years and it will not become less with the coming new Medical Device Regulation. This part of course will focus on the standards and guidance given, how to make a literature search and plan for clinical evaluation, the report and the feedback system.
To give an understanding of the process to run clinical evaluations and how to keep the evaluation up to date during the life cycle of a medical device.
Clinical affairs, QA/RA specialists, risk managers, management, design & development engineers, customer support/service and marketing.
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.
Course material is in English, presentation in English
2nd October 2020. The exact timetable will be specified.
Online Seminar: „GoToTraining“ application
Is needed: internet connection, laptop or PC, google chrome internet browser
400,- € excluding VAT. DNV GL clients could apply 10% discount
Note: Czech VAT will be applied for all participants.