MDR and medical device software – Free QAdvis breakfast seminar, Lund
January 30 @ 08:00 - 10:00Free
MDR and medical device software – Free QAdvis breakfast seminar
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
- Post-Market Surveillance
- MDR implementation timeline for manufacturers
- Additional aspects for software devices
The presentation will be held in Swedish, with material in English.
This seminar will be presented by QAdvis Senior Quality and Regulatory Consultant Emma Axelsson and Principal Consultant Robert Ginsberg.
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.
Do you have a specific question or topic, that you would like us to discuss during the seminar? You can submit your suggestion or question in the registration form below. If we do not include it, there will be an opportunity to discuss after the seminar.
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.
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If you have any questions or want to get in contact with us, use firstname.lastname@example.org or 08-621 01 05.