Fundamentals you need to know – latest updates – how to prepare
You will learn more about the new regulations for medical/in vitro diagnostic medical devices. Date of application 26 May 2021 respective 2022. The time is tight and some of the actions needed for getting your devices ready are both time consuming, complex and depending on others, e.g Notified Bodies.
- The new requirements at a glance – what are the main differences and common topics between the directives and the regulations?
- Some of the current hot topics in MDR
- Some of the current hot topics in IVDR
- Status regarding designation of Notified Bodies
- How to proceed to MDR?
- How to proceed to IVDR?
The presentation will be held in Swedish, with material in English.
The webinar will be administrated as a Zoom webinar.
You will get detailed information for how to attend, in the confirmation email 2 days before the event.
Speakers: QAdvis Senior Quality and Regulatory Consultants Anna-Karin Areskog and Anneli Wiedenkeller
We are longtime trusted providers of MedTech quality and system management, risk management, compliance, training, interim management and regulatory affairs. Offering a thorough knowledge and understanding of the industry, based on 30 years of professional experience, QAdvis have the tools to help take your MedTech innovations to domestic and international markets.