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Software as a Medical Device Classification – Clarification of MDR Rule 11

10 juni
09:00 - 10:30

Webinar

New rules under the MDR for the classification of medical software will push some software and apps to a higher risk category than they would have previously been registered (under the MDD). Many that were in Class I will now be Class IIa or higher — this is particularly relevant for smaller companies: products in the higher categories cannot be self-certified so developers will have to engage with a notified body to conduct conformity assessment.

We will be having a round table discussion with experts in the field to explain and give clarity to this complex topic. During this 1 hour webinar we will answer your questions and give examples of how to move SaMD through the regulatory framework. When registering for this webinar you will be able to submit your questions relating to your device and get real advice from our panel of regulatory professionals.

Panelists:

  • Janette Benaddi (Key note speaker) – Medical Device Expert
  • Per-Anders Elvertrø – Regulatory Affairs Manager, Inventas AS
  • Arnar Kristjansson – Partner, Xybel AS
  • Kami Faust – Regulatory Advisor, Norway Health Tech
  • Anita Moe Larsen (Moderator) – Head of Communications, Norway Health Tech

Target group:

All looking for MDR guidance, specifically for manufacturers looking for guidance on of Software as a Medical Device

This is a free webinar

Påmelding

Speakers

Kami Faust

Regulatory Advisor - Norway Health Tech

kami.faust@norwayhealthtech.com

Janette Benaddi

Consultant - https://www.obelis.net/

jbenaddi@outlook.com

Per-Anders Elvertrø

Regulatory Affairs Manager - Inventas AS

per-anders.elvertro@inventas.no

Dr. ing Arnar Kristjansson

Partner - Xybel AS

arnar.kristjansson@xybel.com