Webinar: Start your journey to IVDR certification

May 30, 2024 online
Manufacturers need to comply with European regulations to ensure that their innovative and continuously developed IVDs are safe and perform well. DEKRA Certification B.V. is a Notified Body designated by the European Commission under the new EU regulation on in vitro diagnostics (IVDR 2017/746).
Date: Thursday, 30 May 2024
Time: 09:00am – 10:00am or 3:00pm - 4:00pm (CET)
Location: Online
In this webinar, you will gain insight into how to start your journey to In Vitro Diagnostic Regulation (IVDR) certification. We aim to provide manufacturers with an understanding of the key steps involved in the process of obtaining an IVDR certification and offer an opportunity to ask questions.

Three DEKRA IVDR experts will cover the following topics:

  • Steps towards product certification under IVDR at DEKRA.
  • What steps do you need to take and what can you expect?
    • QMS audit
    • Technical file
  • How can DEKRA, as a Notified Body, be of service?
  • Lessons learned

Guest speakers:

Liz Gommans, PhD
Liz Gommans joined DEKRA Certification B.V. over 4 years ago, where she is a qualified technical file reviewer for IVDD and IVDR. She is actively involved in the IVDR-related regulatory affairs activities of DEKRA. Liz studied molecular life sciences in the Netherlands and obtained her PhD in the field of glycobiology, performing research at the interface between chemistry and biology. After her PhD, she worked in the industry as a researcher in the IVD field, developing quality controls for near-patient clinical chemistry and many other types of IVD tests.
Freddy Godeke
Freddy Godeke joined DEKRA Certification B.V. in 2019 and qualified as a Project Manager, Lead Auditor, TF Reviewer, and PE Reviewer with a background in Clinical Chemistry. He has 17 years of experience in two different hospitals with a specialization in Hematology, 4 years of experience in the IVD industry, and 2 years of experience in the active pharmaceutical ingredients industry.
Tamara Garcia
Tamara Garcia joined DEKRA Certification B.V. in 2018. She is a Sales Manager & Account Manager for the Notified Body and Approved Body (DEKRA Certification UK Ltd) and is responsible for the global sales process and marketing activities.

We look forward to welcoming you!

A recording of the webinar will be made available post-event for those who are unable to attend live.