Evidence Throughout the Lifecycle: Integrating Clinical Needs into Design & Documentation

Struggling to demonstrate the safety, performance and benefits of your medical device software under the MDR?

On demand

1h

Medical Devices

English

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This webinar will explore the essential clinical evidence needed for success, including investigations, literature reviews, technical performance, and the use of similar devices.

We’ll discuss the critical role of clinical validation starting from the design phase and guide you on how to compile the necessary evidence to meet MDR requirements.

By attending, you’ll learn how to ensure your software not only achieves market access but also upholds patient safety and delivers effective healthcare outcomes.

Speaker

Pia-Gyselen-1

Pia Gyselen

Lead Medical Writer

Pia is an experienced expert with 26 years in the medical industry. She holds a Master’s degree in Medical Biochemistry from the University of Antwerp,

Currently, Pia leads the Medical Writing team at QbD Clinical, overseeing the creation of regulatory documents for medical devices, in-vitro diagnostics, and clinical research. She collaborates with cross-functional teams to ensure compliance and accuracy in regulatory submissions.

Previously, Pia was the Lead of Clinical Operations at Fluidda, where she shaped the department and managed the team. She also held senior roles at Janssen Research & Development, where she managed large-scale global clinical trials, focusing on strategic planning, risk management, and operational execution.

Pia is a lifelong learner who thrives on tackling multiple projects and enjoys brainstorming innovative solutions, mentoring others, and turning ideas into action.