Our services include:
• Quality management support
• System development
• Clinical evaluation
• Medical device software specialist services
• Regulated software validation
• Quality and regulatory consulting
• Training
• European Authorized Representation

A free breakfast seminar from QAdvis.

In Vitro Diagnostic Regulation 2017/746 (IVDR)

Welcome to this free breakfast seminar, where you will learn more about the impact and implications of the new IVDR, which applies from 26 May 2022. That date may seem far away, but time is tight, as some of the actions needed for getting your devices IVDR ready are both time consuming and complex.

In this seminar, we will discuss the following:

  • What is going on at the moment regarding the new IVDR and MDR regulations
  • The current status of IVDR and MDR implementation at Notified Bodies and Competent Authorities
  • The new requirements at a glance – what are the main differences between IVDD and IVDR?
  • IVDR implementation timeline
  • Examples of implementation steps

The presentation will be held in Swedish, with material in English.
Speakers QAdvis experienced consultant Emma Axelsson, Kista and Anna-Karin Areskog, Lund

Agenda Coffee and breakfast from 8.00, seminar 8.30–9.30, with time for questions afterwards

Date and location
3 September, Lund – Ideon Konferens Alfa-huset (Forum), Scheelevägen 15, 223 63 Lund
Register for the Lund seminar here

5 September, Stockholm – Kista Entré Konferens, Knarrarnäsgatan 7, 164 40 Kista
Register for the Stockholm seminar here

The event is free but tickets are limited, we apply a no-show fee of SEK 300

To sign up for our mailing list, to receive information on our upcoming seminars and courses – go here.

If you have any questions or want to get in contact with us, use info@qadvis.com or 08-621 01 05.