点播网络研讨会

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

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

Medical Devices

随时观看

60 分钟

Clinical · Medical Devices

Chinese

Contents

Chapters

00:00Introduction
05:45Regulation & Guidance
07:40Clinical Evidence
16:49General Safety Performance Requirements
17:59Systematic Literature Review
23:02Clinical Evaluation
35:22Benefit Risk Assessment
46:02Q&A

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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.

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

What you'll learn

Gather and compile robust clinical data to support your conformity assessment.
How the classification of your MDSW impacts clinical validation requirements.
Best practices for integrating clinical validation considerations into your design process.
The importance of clinical evaluation for technical documentation and market access.

向最优秀的人学习

演讲者

Join us as our expert speaker shares valuable insights and practical knowledge drawn from extensive industry experience.

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.

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