Today SFL’s CEO and MPP’s President Shayesteh Fürst-Ladani presented at the training course hosted by MPP on connected combined products. She gave an overview of the EU regulatory framework for medicinal products and medical devices and outlined the regulatory challenges for products combining medicinal products, medical devices and digital components.

She underlined the need “to develop a regulatory framework fit for purpose for connected combined products, that ensures safety and data privacy, fosters innovation and allows for a flexible approach of the components depending on their intended use”.

SFL’s experienced medical devices team performs gap analyzes and creates, reviews and updates technical documentation, clinical performance evaluation as well as quality and risk management systems under the Medical Devices Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR).