Free seminar – Medical device standards and EU harmonization progress
Standards are voluntary (well, almost all) but are still very important elements in demonstrating compliance with the regulatory requirements in EU MDR 2017/745 and IVDR 2017/746. This breakfast seminar provides a background to the purpose and benefit of European harmonized standards, the current status and the ongoing work driven by the EU Commission. The seminar in a follow-up of a previous webinar a year ago and will give an insight and update on the big picture
Topics
What is going on in MDCG Standards?
Why is everything taking so long time?
What can be done by the manufacturer in the absence of harmonized standards?
What does “state-of-the-art” mean?
Speaker: Nils-Åke Lindberg, Founder of QAdvis and Sr Principal Consultant
Seminar language: Swedish, with English slide support. Any questions in Swedish/English.
Welcome to get some breakfast from 08.30, meet our speaker and mingle with other industry colleagues.