Introduction to IVDR - demystifies the conformity process, what manufacturers should expect, and preparing for successful engagement throughout the conformity assessment process. 

The session will conclude with an open fireside discussion, allowing you to ask questions directly to experienced industry and Notified Body experts.

Agenda

  • Welcome and introduction 
  • Understanding the role of the Notified Body under IVDR
  • Preparing for your first conformity assessment
  • Fireside discussion and audience Q&A 

What you will learn

  • What a Notified Body is and why one is required under IVDR;
  • The stages of the conformity assessment process;
  • The documentation and evidence required before submission; and
  • Best practice guidance through an interactive fireside Q&A.

Speakers

Alex Laan
Head of IVD Notified Body, BSI
Maria Kelly
Associate Global IVD Head, BSI
Victoria Cox
Western Sales Manager – EMEA, BSI
Johnathon Bis
Commercial Operations Director, Regulatory Services Americas, BSI

Questions? Contact us at: us.medicaldevices@bsigroup.com

Enter your first name
Enter your last name
Enter your job title
Enter your company name
Enter your phone number
Select your country
Enter your postcode
Submit your questions for our technical and commercial team.
Please read the BSI Privacy Notice for further information regarding your rights.