We are delighted to welcome you to The International Symposium on Medical Devices  Cost-Effective Clinical Investigation & Evaluation (MDCI 2023), which will be held on June 26-27, 2023 in Brussels, Belgium.

Medical device and IVD manufacturers, as well as regulators and notified bodies, are currently facing challenging times. However, it is important to consider the opportunities that come with these challenges, even if they were not initially part of the manufacturers’ or regulators’ plans. For many years, we have been emphasizing that well-designed clinical investigations should not be seen as a pure cost center, but rather as a return on investment opportunity.

Under the current regulations, strong data sets are crucial to demonstrate patient safety and clinical benefits, as well as to ensure successful market access. Such data sets are as good as gold in the hands of a salesperson.

This symposium is designed to provide a wealth of information for clinical professionals, project managers, notified bodies, and regulators from around the world, with a particular focus on the following practical areas:

• A full-day workshop providing an in-depth review of the Clinical Evaluation documentation under EU MDR.
• An update on ISO 14155:2020 – Clinical investigation of medical devices for human subjects – Good Clinical Practice.
• How to develop the right study design for global or European market access.
• Regulatory updates in clinical evaluation and investigations.
• Several open-floor discussion opportunities.