“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”
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 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/
- Developments in the EU for products on the pharmaceutical / medical device borderline
About SFL Regulatory Affairs & Scientific Communication Ltd:
SFL provides a holistic approach to lifecycle management of healthcare products from nonclinical and clinical studies through to registration and post-approval activities. The company’s team of professionals have experience in Regulatory Affairs, Public Affairs, Legal Services and Medical Communications. SFL supports its clients by offering personalized and comprehensive services. When combined, these services provide an integral oversight package for products from the bench to the marketplace at one consultancy.