Dr. Tina Amini, a pharmacist with PhD in Pharmaceutics. She has over 30 years experience in Pharmaceutical and Medical Devices. She previously held the positions of Head of Notified Body and Senior Technical Specialist at LRQA Notified Body and Pharmaceutical & Medical Device Expert at bsi Notified Body, where she was responsible for Device Drug combination products, Conformity Assessment of a wide range of medical devices and onsite assessments of Quality Management System (QMS) as the lead auditor.
Tina has extensive experience of regulatory expertise for CE marking of medical devices, and has been involved in the classification of borderline products and consultation process with several EU competent authorities and EMA for device/drug products.
Prior to joining Notified Bodies, Tina worked in the Pharmaceutical Industry in a variety of disciplines where she took products through from discovery to commercialisation.
Practical guidance on borderline Issues and combination products