The new regulatory framework in Europe, in addition to updated MEDDEV guidance continue to monopolize clinical and regulatory professionals’ focus, as the transition period of time to meet compliance is swift. From one device company to another, practical approaches to the new requirements and prioritization of implementation operations greatly vary, depending on the product class, size of the clinical team, and available budget. Diving into peers’ efforts and experience thus far in remodeling the clinical regulatory strategy is crucial to gain insight into encountered paths and pitfalls.
Dr. Mattia Ronchetti
Director – Oncology Clinical, R&D