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.
Location *
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
Dates and location
Lund
TBD
Stockholm
TBD
Webinar *
TBD
Prices
Free of charge.
Customized training courses and seminars
We provide training courses and seminars, both as open courses / seminars and
as customer specific trainings.
Registration
Registration will be available as soon a new event is launched
Questions: email us or call +46-(0)8-621 01 05.
QAdvis is a solution-oriented trusted service provider for the medical device and in vitro diagnostic device sector. To enable and maintain global market access, we can with high level of knowhow and expertise within quality management and regulatory affairs support your company to be in compliance with applicable regulations and requirements. QAdvis was founded in 2013 and is based in Sweden. We are certified according to ISO 13485:2016.
