About this event
This informative webinar is intended for manufacturers that want to have more information on risk management, performance evaluation and post-market surveillance, in order to comply with the IVDR.
Key Topics Covered:
- Risk management: The basic risk management approach and lessons learned
- Performance evaluation: More insight into scientific validity, analytical performance and clinical performance
- Post-market surveillance: Information regarding new IVDR PMS requirements related to audit and technical documentation
Why Attend?
Participants will gain knowledge essential for being compliant to the IVDR for different topics. This session will empower you to:
- Understand the risk management process under the IVDR
- Prepare for performance evaluation documentation and explain the expectations
- Identify the requirements regarding PMS and PMPF
Target Audience
This webinar is ideal for manufacturers focused on IVD products.
We process your data in our customer relationship management system for the purpose of your registration to our webinar. You can find more information in our data privacy information.
Hosted by
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External speaker
Freddy Godeke Project Manager, Lead Auditor, TF and PE Reviewer @ DEKRAE
Freddy Godeke joined DEKRA Certification B.V. in 2019 and qualified as a Project Manager, Lead Auditor, TF Reviewer, and PE Reviewer. He has a background in Clinical Chemistry, with 17 years of experience in two different hospitals specializing in Hematology, 4 years of experience in the IVD industry, and 2 years of experience in the active pharmaceutical ingredients industry.
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External speaker
Liz Gommans Technical File Reviewer for IVDD and IVDR IVDR @ DEKRAE
Liz Gommans joined DEKRA Certification B.V. over 5 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 on the interface between chemistry and biology. After her PhD, she worked in industry as a researcher in the IVD field, developing quality controls for near-patient, clinical chemistry, and many other types of IVD tests.
DEKRA
On the safe side.DEKRA is a global expert organization dedicated to safety, with over 48,000 employees in around 60 countries. They provide a wide range of independent expert services for safety in transportation, workplaces, and homes.
