Gaining and retaining medical devices on the market – practical experiences

Bringing and keeping medical devices to market is a complex process that poses several challenges. What is the roadmap for bringing scientific research to market? How do you comply with the Medical Device Regulation (MDR)? Unitron, Baat Medical, Holland Innovative and the TechMed Center will share their experiences and knowledge to help you further.

What: MedTech Twente knowledge session
Date: Thursday, 14 March 2024
Time: 8:45 – 13:00 hrs (incl. lunch)
Location: TechMed Centre, University of Twente (Enschede)
Language: Dutch
Optional: TechMed Centre guided tour (starting 13:00 hrs)

PROGRAM

8:45 – 9:00 hrs | Walk-in with coffee and tea

9:00 – 9:15 hrs | Welcome by MedTech Twente

9:15 – 10:00 hrs | From science to market. Implications of the MDR, by Peter Oosterhoff, MedTech QA & RA Expert at TechMed Centre | University of Twente

The introduction of the MDR also has implications for clinical research on new medical technologies. Involved parties are still searching for the correct interpretation of the new regulations. In this session, we explore the possibilities for early-phase feasibility studies by research institutions and the transition to a commercial MDR trajectory.

10:00 – 10:45 hrs | The influence of the MDR on medical device development, by Arthur Aalsma, Director of R&D at BAAT Medical Products BV

In this session, we will explore the requirements of the MDR for both the product and the development processes. Discover the essential role that risk management plays in this regard using a real-life case study.

10:45 – 11:00 hrs | break

11:00 – 11:45 hrs | MDR and outsourcing; how does it work?, by Nico Zeeders, Manager Regulatory Affairs at Unitron and Manuela Meijer, Quality Manager at Unitron

The MDR holds the medical device manufacturer responsible for all processes related to the safety and quality of the product. In most cases, however, the manufacturer does not perform some of these processes himself; he outsources them to a subcontractor. How exactly does this outsourcing work under the MDR? In this session, we will share our experiences based on a case study and tell you how, as a manufacturer, you can best arrange and control the outsourcing of your process.

11:45 – 12:30 hrs | Clinical Evaluation and Post-Market Surveillance, by Lisanne Nanning (Holland Innovative). Lisanne is a Medical Devices Development Specialist with a focus on Clinical Evaluation.

This session aims to equip participants with the key elements of the requirements for Clinical Evaluation and Post-Market Surveillance as outlined in the MDR. In addition, the session will provide you with practical insights based on our best practices for integrating Clinical Evaluation and Post-Market Surveillance into your product development process.

12:30 – 13:00 hrs | Lunch

Ca. 13:00 hrs | TechMed Centre guided tour (with reservation)

More information: https://medtechtwente.nl/nl/events/medische-hulpmiddelen-op-de-markt-krijgen-en-houden/