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.
Programme
08.45 - 09.00 | Walk-in with coffee and tea |
09.00 - 09.15 | Welcome by MedTech Twente |
09.15 - 10.00 | From science to market. Implications of the MDR 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 | The influence of the MDR on medical device development 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 | Break |
11.00 - 11.45 | MDR and outsourcing; how does it work? 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 | Clinical Evaluation and Post-Market Surveillance 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 | Lunch |
13.00 - 13.45 | TechMed Centre guided tour (with reservation) |
Registration
Although this is a free event, please note that registration for this event is not obligation-free. If you cannot attend the event for which you have already registered, we kindly ask that you let us know by sending an email to this email address.
Organisation
MedTech Twente is the innovation cluster where medical technology is accelerated. Here, businesses and health care institutions work closely together with researchers from the knowledge institutes to invent innovations for the health care of the future. Innovations are being developed, validated and implemented in close collaboration with parties, facilitated and accelerated by supporting organizations such as Novel-T, Oost NL, TechMed Centre | Universiteit Twente, Kennispark Twente, World Trade Center Twente, Hogeschool Saxion and Health Valley Netherlands. It’s also not surprising that successful MedTech companies such as Demcon, Medspray, Micronit, Lipocoat and IamFluidics were founded and grown in Twente.
