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April 2024


16 April

11:00 AM - 12:00 PM ET | 5:00 PM - 6:00 PM CET

Sponsored By:

Aligning Your QMS with the FDA's QMSR Updates


Virtual Event

Speakers:
Nancy Morrison, RAC - Vice President, Intelligence & Innovation

Join us for an insightful 30-minute webinar where RQM+ Vice President of Intelligence & Innovation, Nancy Morrison, RAC will dive into the upcoming changes. Understand the critical updates, from design controls and risk management to traceability and record-keeping requirements. Discover how these changes aim to streamline processes, enhance device safety and performance, and foster a more global alignment in quality management practices.

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25 April

11:00 AM - 12:00 PM ET | 5:00 PM - 6:00 PM CET

Sponsored By:

Live! #78 – Behind the Scenes with BSI Head of IVD Notified Body, Alex Laan


Virtual Event

Speakers:
Alex Laan Head of IVD Notified Body, BSI
Margot Borgel Director of IVD Global Regulatory Affairs, RQM+

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.

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May 2024


05 May - 07 May

Presented By:

RAPS Euro Convergence


Berlin, Germany

Speakers:
Dr Margot Borgel, Director, IVD Intelligence & Innovation RQM+

Stop by our booth and join our speaking session on the 7th of May on the topic, "Clinical Performance Studies Under IVDR"

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