During the session on Wednesday 27 February, Shayesteh will be giving a presentation entitled “Optimum classification, conformity assessment and regulatory route for drug/device combinations”. In her talk, she will be giving clear guidance on the different types of combination products, the regulatory route for each classification and requirements to be fulfilled. Furthermore, she will outline proposed changes in the Medical Device Regulation impacting manufacturers of combination products.
“It is important that medtech companies monitor changes in requirements very closely and implement compliance measures timely” commented Shayesteh.
Shayesteh is the Managing Director and founder of SFL. She has comprehensive experience in formulating global regulatory strategies and provides support for the development of drugs, orphan drugs, drug & device combination products, borderline products, medical devices, in vitro diagnostics and advanced therapy medicinal products.
Shayesteh is Chair of the 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 and will present on the revised Directives for medical devices and in vitro diagnostics at the upcoming DIA EuroMeeting in Amsterdam
Shayesteh has recently published a number of articles about medical device regulation and related regulatory areas, which are available on the SFL website.
Recently published SFL articles about medical device regulation:
Device Advice
http://www.sfl-services.com/files/news/40_SFL_EPC.pdf
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?
http://www.sfl-services.com/files/news/37_PP2301_Borderli…
Developments in the EU for products on the pharmaceutical / medical device borderline
Source Article from http://www.prlog.org/12076045-sfls-managing-director-invited-to-speak-at-medtec-europe-event-in-stuttgart-germany.html
