Under the IVDR, performance evaluation is a cornerstone of compliance, yet many IVD manufacturers underestimate the level of scientific and clinical evidence required.
Join Our Expert-Led Webinar and Gain Crucial Insights On:
- how to build a robust performance evaluation.
- differences between scientific validity, analytical performance, and clinical performance.
- common pitfalls and insufficient documentation.
In this session, Tom Patten will explain how to build a robust performance evaluation that meets regulatory expectations, highlighting the differences between scientific validity, analytical performance, and clinical performance. Real case examples will illustrate common pitfalls and insufficient documentation that often lead to delays or nonconformities, helping manufacturers better prepare and strengthen their technical files.
Tom Patten is the IVD International Manager at GMED. He brings broad and varied experience from within the in-vitro diagnostics sector, having worked in laboratories, product development, and R&D for molecular oncology devices. Over the past seven years, he has also gained notified body experience, contributing to the successful designation of an IVD body under the IVDR 2017/746. In his current role, Tom supports manufacturers with global IVDR/IVD regulatory strategy, structured dialogue sessions, and international market access.
- 26.01.26 Monday
- 13:00-14:00
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To access the registration form, please click here.