Evidence Throughout the Lifecycle: Integrating Clinical Needs into Design & Documentation
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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.
Speaker
Join us as our expert speaker shares valuable insights and practical knowledge drawn from extensive industry experience.
Don’t miss the opportunity to learn and engage with professionals in the field.
Pia Gyselen
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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