SFL’s CEO Shayesteh Fürst-Ladani will chair a session on the new Medical Device Regulations (MDR) at the upcoming DIA Europe 2020 meeting (17-19 March, Brussels). The session entitled “MDR Implementation – Status Quo” (#S0806) will explore the new requirements related to technical documentation, Periodic Safety Update Reports (PSUR), Summary of Safety and Clinical Performance (SSCP), Quality Management Systems (QMS) and clinical investigations for certification of medical devices under the EU MDR.

Shayesteh is an expert in EU and US regulations, including the EU MDR, having participated in reviewing and assessing the impact of legislation in these regions for both pharma and medical device products, as well as combined products with  drug, device and software components that are the focus of the Medtech & Pharma Platform (MPP) Association for which she is the President. Furthermore, Shayesteh is Adjunct Instructor for Regulatory Affairs at the George Washington University and Lecturer at IFPMA/Kings College.

Shayesteh would be happy to meet with you at the session or SFL’s booth (#J10), or you can contact SFL to arrange a call to discuss how SFL’s interdisciplinary teams, covering Medical Devices, Combination Products, Regulatory Affairs, Medical Affairs, Quality Assurance and Supply Chain, can support you to ensure your medical devices and combination products conform to all requirements under the new MDR.