Telling the Clinical Story from a Regulator´s Perspective

Join us for an insightful afternoon designed to help leaders in the Life Science and MedTech industries navigate regulatory expectations. This event is particularly valuable for CEOs and decision-makers in young companies, providing key knowledge on clinical evidence and post-market clinical follow-up (PMCF) planning.
Learn directly from TÜV SÜD experts about regulatory requirements, so you can determine how to meet regulatory requirements efficiently and avoid common pitfalls.
TÜV SÜD is a Supporting Partner of Medicon Village and together we invite you to an engaging afternoon. The event is part of the TÜV SÜD Insight Programme at Medicon Village.
Key Take aways
- Regulatory Readiness: Understand what regulators expect from clinical evidence and post-market clinical follow-up planning.
- Risk Mitigation: Learn how to avoid costly non-conformities that could delay market entry.
- Practical Insights: Hear real-world examples of common compliance challenges and how to address them effectively.
- Strategic Decision-Making: Equip your leadership team with the knowledge to develop robust clinical and regulatory strategies.
Programme
12:00 – 13:00 Lunch & Networking
An opportunity to connect with industry peers and experts.
13:00 – 13:30 Understanding Regulatory Expectations
Gain insights into how TÜV SÜD supports MedTech companies with services, which helps you to navigating towards compliance throughout the lifecycle of medical devices. Learn about regulatory, requirements, expectations and how to prepare your company for successful approvals.
Presenter: Theresa Larriba Harboe, Head of Client Relations, TÜV SÜD – Medical Health Services.
13:45 – 14:00 Bio-Break
A short pause before diving into regulatory requirements.
14:00 – 15:00 Telling the Clinical Story from a Regulator’s Perspective, Part 1
- Understanding Clinical Evidence requirements for medical device claims and intended purpose.
- Common mistakes in clinical evidence and how to avoid them.
Presenters: Mette Sørensen & Maj Kornø, Internal Clinicians, TÜV SÜD – Medical Health Services.
14:45 – 15:00 Fika & Discussion
A break to reflect and discuss insights with peers.
15:00 – 15:45 Telling the Clinical Story from a Regulator’s Perspective, Part 2
- Requirements for Clinical Evidence related to device claims and intended purpose. This will support you to determine strategic approaches towards regulatory compliance for PMCF planning based on clinical evaluation outputs.
- Avoiding common pitfalls in PMCF for regulatory success.
Presenters: Mette Sørensen & Maj Kornø, Internal Clinicians, TÜV SÜD – Medical Health Services.
15:45 – 16:00 Open Discussion & Q&A
An interactive session where attendees can ask specific questions about clinical evidence and regulatory challenges.
Meet the Experts
- Theresa Larriba Harboe, Head of Client Relations, TÜV SÜD – Medical Health Services.
- Mette Sørensen, Internal Clinician, TÜV SÜD – Medical Health Services.
- Maj Kornø, Internal Clinician, TÜV SÜD – Medical Health Services.
About TÜV SÜD
For over 30 years, TÜV SÜD has provided certification and testing services for manufacturers and suppliers of medical devices and in vitro diagnostics. We have in-depth knowledge of the medical devices and IVD market and our dedicated team of experts, engineers, and medical doctors provide assessments that cover the full life cycle of your products. We are global, we are multilingual and have experts in all major markets who provide tailored services based on industry regulations and requirements.
Information
- When: to
- Where: Sharience, The Spark building, Medicon Village, Scheeletorget 1, Lund
- Organizer: Medicon Village in collaboration with TÜV SÜD
- Language: English
Registration
Please register no later than Tuesday 4 March 2025
Contact information
- Lottie Norrsén
- lottie.norrsen@mediconvillage.se