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
Global Head, IVD Regulatory Services
Victoria
Cox
Western Sales Manager – EMEA, BSI - AM Session
Johnathon
Bis
Commercial Operations Director, Regulatory Services Americas, BSI - PM Session
Riley
Li
Business Development Manager, APAC China, BSI - AM Session
Hyunjung
Koo
Senior Business Development Manager, APAC Korea, BSI - AM Session
