Ibim Tariah, Ph.D.

Technical Business Development Director—Medical Devices for SGS North America Inc.

Dr. Ibim Tariah is the technical director, business development Medical Devices at SGS North Americas, responsible for EU Regulations implementation, regulatory affairs training activities, and support to Medical Devices commercial activities. Dr Tariah’s vast experience spanning over 25 years in European regulatory affairs includes regulatory knowledge of combination devices incorporating biologics, drugs, and drug-biologics together with quality management systems assessment of medical devices. His expertise lies in innovative vascular, orthopedic and dental, and other long-term implantable devices for clients needing technical documentation assessment and reviews in compliance with the Medical Device Regulations (MDR). He also acted as a liaison with regulatory authorities including MHRA (UK), European Medicines Agency (EMA), and Medical Products Agency (Sweden). Dr. Tariah earned his Ph.D. in Materials Science with emphasis on polymer science and technology from the University of Manchester, U.K.

9:45-10:30 a.m

Wednesday April 24, 2024

Regulatory Update: A Sector in Transition

The worldwide regulatory landscape has been in a state of flux for some time. While some changes were planned, others have been the result of outside forces (e.g., pandemic). This session will provide an overview of the most important MDR changes affecting the EU medical device market, as well as highlight a number of FDA initiatives that are important to manufacturers. Best practice recommendations in navigating these rough waters will be provided.