SFL’s Head of Combination Products Theresa Jeary will present at the “An Introduction to the Medical Device Regulation” event of the Management Forum (11-13 November 2019, London). Theresa’s presentation will address the impact of the incoming MDR on conformity assessment and medical device manufacturers and distributors, with a particular focus on the complex area of device or drug/device combinations incorporating material(s) of animal origin.

Theresa is an expert in medical devices and combination products and was previously Head of a Notified Body for Medical Devices, providing full support in preparation and implementation of MDR requirements in companies’ operations, strategies and documentations. She will be accompanied by Marta Swierczynska who is specialized in regulatory writing for medical devices and combination products. SFL provides complete lifecycle support for medical devices, from strategic advice on development to clinical evaluation, QMS, CE‑marking and post-marketing maintenance. Theresa and Marta would be happy to speak with you at the event, or please contact us to arrange a meeting to discuss how SFL’s Medical Devices and Combination Products Teams can support you in MDR implementation, as well as maintenance documentation for your products.