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If you have ever thought to yourself "I wonder what the notified body is thinking?" ...this is a conversation you want to hear.

The involvement of notified bodies under the previous IVD directive was limited to a small number of analytes and device types. As a result, many IVD manufacturers have never worked with a notified body and are now trying to understand how notified bodies operate and navigate the complex path towards IVDR certification.

In this conversation, Margot Borgel, RQM+ Director of IVD Global Regulatory Affairs, sits down with Head of IVD Notified Body at BSI, Alex Laan. The conversation will explore the inner workings of an IVDR notified body and shine light on how the notified bodies work with other key stakeholders, set expectations for manufacturers, and navigate the constantly changing landscape of IVDR.

By attending this free event, you will gain an understanding of how the notified body operates, which will allow more confident and informed interactions as you move through IVDR certification and beyond.

The discussion will include:

  • How notified bodies interact with competent authorities and other notified bodies
  • How new guidance and changes to IVDR are implemented within the notified body
  • How expectations are set and consistency is maintained for IVDR certification
  • What notified bodies wish manufacturers knew

RSVP by completing the form and we'll email connection details.

PARTICIPANTS

Alex Laan
Head of IVD Notified Body, BSI

1599474626674-1Alex Laan recently joined BSI as the Head of IVD Notified Body. In this position, Alex will be focusing on further strengthening the regulatory foundations within the IVD team and make BSI future-proof for the years to come in the challenging regulatory environment in the EU for IVD’s. 

Alex is originally a biochemical engineer and worked on the design and development of ELISA based assays in virology and immunohematology tests. He has worked a technical specialist in reagents and tests at Sanquin blood bank located in Amsterdam. 

He holds degrees in Biomedical Chemistry, Biotechnology and Business Administration.


Margot Borgel
Director of IVD Global Regulatory Affairs, RQM+

Margot Borgel HeadshotMargot Borgel, Ph.D. is the Director for IVD Intelligence and Innovation at RQM+ where she provides her expertise in IVDR implementation and notified body requirements. Prior to RQM+, Margot was a Technical Specialist at BSI, where she performed technical reviews for IVDR, IVDD and UKCA certification. She is especially passionate about certification of high-risk devices and enjoyed seeing these devices through IVDR certification while at BSI. Before her notified body work, Margot worked for Immucor, Inc. where she held roles in R&D, manufacturing technical support and manufacturing.

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