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.

MDR and medical device software

Welcome to this free breakfast seminar, where you will learn more about the impact and implications of the Medical Device Regulation, MDR, and some aspects of its effects on medical device software. In this seminar, we will discuss the following:

• The current status of MDR implementation at Notified Bodies and Competent Authorities, and latest news
• The new requirements in short – main differences between MDD and MDR
– Classification rules
– The certification process
– General Safety and Performance Requirements (GSPR)
– Technical documentation
– Clinical evaluation
– EUDAMED
– UDI
– Post-Market Surveillance
• MDR implementation timeline for manufacturers
• Additional aspects for software devices

The presentation will be held in Swedish, with material in English.

Speakers
This seminar will be presented by QAdvis consultants Robert Ginsberg, Emma Axelsson and Anneli Wiedenkeller.

The seminar provides an overview of the Medical Device Regulation and the key changes it necessitates for medical device manufacturers. It introduces some of the contents of the upcoming QAdvis courses Software Development according to IEC 62304 in February 2020 (2-day course) and Medical Device Regulation in March 2020 (1-day course). Read more about these courses here.

Date, Time and Location
Tuesday, January 28, 2020, 8:00 – 10:00
Coor – Kista Entré (Lokalen Alfa)
Knarrarnäsvägen 7, Kista. View Map.

Take me to the registration (extern link).

Thursday, January 30, 2020, 8:00  – 10:00
Ideon Konferens Alfa-huset (Forum)
Scheelevägen 15, Lund. View Map

Take me to the registration (extern link)

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

Note
The event is free but space is limited – register to participate. If you register but don’t show up, you will be charged 300 SEK.

Sign up for our mailing list here, to receive more information on our seminars and courses.

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