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QTEC Academy Seminar, Hamburg

Event Date: 25/09/2024 to 26/09/2024

Location: Hamburg, Germany



In May 2022, the transition period of the previous Directive 98/79/EC on in vitro diagnostic medical devices (IVDD) ended. This closed the last back door for a possible simplified market approval for IVDs. Since then, the full scope of EU Regulation 2017/746 on in vitro diagnostic medical devices (IVDR) has applied. Many manufacturers of IVD products suddenly find themselves faced with significantly higher and more complex requirements under the IVDR than before.

Join our SME’s Amanda Ball (Head of Global Clinical Operations) and James Lappin (Head of Clinical Compliance & Quality Assurance) In this two-day conference, where you will not only expand your specialist knowledge of the IVDR, but will also come into direct contact with notified bodies, authorities and other manufacturers, allowing you to better understand the different perspectives of the stakeholders, exchange experiences and expand your network of expertise.

Day 1: 25th September 

Amanda Ball will be presenting "A Journey through Clinical Performance Study startup and monitoring: A how to guide on best practices and pitfalls."

Day 2: 26th September

James Lappin will be presenting on "CDx performance study requirements and submissions under IVDR"

We hope to see you there!

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