Basel, Switzerland, September 22, 2012 --(PR.com
)-- Shayesteh Fürst-Ladani, Managing Director of SFL Regulatory Affairs & Scientific Communication Ltd (SFL), has been invited to give a presentation at the World Medtech Forum in Lucerne on Wednesday, September 26. Shayesteh’s presentation will be entitled “How to prepare for medtech regulatory changes – Insights into recent developments at the European Commission.” During Shayesteh’s talk, the audience will learn about the current medtech regulatory framework in Europe, anticipated changes by the Commission and how they might impact the industry.
“The existing EU regulations for medical devices were drafted 20 years ago and so changes to address the current environment have become necessary. It is important that the medtech companies very closely monitor changes and implement measures ensuring timely compliance with the new requirements,” commented Shayesteh.
Shayesteh is the Managing Director and founder of SFL. She leads the team and provides global strategic support for the development of healthcare products. Shayesteh has a comprehensive knowledge base and experience in formulating global regulatory strategy for drugs, orphan drugs, drug & device combination products, borderline products, medical devices, in vitro diagnostics and advanced therapy medicinal products.
Shayesteh is Chair of Combination Products Topic Group at EuropaBio. She has been a member of the Program Committee of DIA EuroMeeting for 2011, 2012 and 2013 leading the Theme Drugs, Devices, In Vitro Diagnostics and their Combinations. Shayesteh is also Chair of the SIAC (Special Interest Area Community) group for Devices & Diagnostics at DIA. In 2012, she received the Open University Business School’s Alumni Award for Outstanding Contribution to an Organization.
Please see two recent articles published by SFL about medical device regulation:
Changes to guidance in the EU and US may simplify the challenging process of product classification for medical device combination products.
Is this the year of more clarity in the EU for products on the pharmaceutical/medical device borderline?
Developments in the EU for products on the pharmaceutical / medical device borderline