Today SFL organized a joint webinar with Swiss Medtech on combined products in the EU and in Switzerland.
Experts in the field of pharma and medical devices from SFL, Swiss Medtech and Novartis provided an overview of the regulatory framework for products combining medicinal product and medical device components and shared their insights on the main challenges for those products.
SFL’s experienced cross-functional teams perform gap analyses and create, review and update technical documentation, clinical performance evaluation as well as quality and risk management systems according to the Medical Devices Directive (MDD), Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) requirements.