Standards, Harmonisation Process and Common Specifications
Standards are voluntary but still very important elements in demonstrating compliance with the regulatory requirements in MDR 2017/745 and IVDR 2017/746.
This webinar provides a background to the purpose and benefit of European harmonised standards, the current status and the ongoing work and steps ahead in the Commission MDCG subgroup Standard.
The session will give an insight and understanding of the big picture. What is going on? Why does everything take such a long time? What can be done as a manufacturer to use the time available in the best way?
- Why standards at all?
- Why harmonized standards?
- State of the art?
- Common Specifications, legal status and planned publications
- MDCG Standards, ongoing work, Task Forces and next steps
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.
- When: to
- Where: Online
- Organizer: QAdvis
- Language: English
Please register no later than Friday 25 March 2022