Get an update on the big picture.
What is actually going on in Brussels?
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.
- 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?
Everyone involved in medical device development, including quality and regulatory professionals, will benefit from this presentation.
Swedish, with English slide support. Any questions in Swedish/English.
Nils-Åke Lindberg, Founder of QAdvis and Sr Principal Consultant
Nils-Åke has more than 35 years of experience in the medical device industry. He is an active member of standard committee SIS/TK355, ISO TC210 for quality management system aspects, e.g., ISO 13485. Board member of European Association of Authorized Representatives and UK Responsible Person Association. Active stakeholder member of EU Commission MDCG working group for Standards.
Dates and location
Welcome to Kista and/or Lund! Enjoy breakfast from 08.30, meet our speaker and mingle with other industry colleagues.
The event is free but space is limited. If you are not able to participate, we urge you to make a cancelation as soon as possible or assign your place to a colleague. If you register but don’t attend, you will be charged 300 SEK.