Event Details

Richard Holborow is Head of Clinical Compliance at BSI. Richard spent 16 years in direct patient care as a clinical physiologist in the National Health Service in the UK, with 8 of those years specialising in implantable cardiac devices. In 2018 , Richard joined BSI to focus his career on regulatory affairs, bringing his clinical knowledge and experience into BSI for preparation of the Medical Device Regulations.

David R Rutledge, Pharm.D., FCCP, FAHA is an accomplished and results-oriented consultant for clinical evaluations and investigations, clinical risk management, regulatory, and quality. He brings 25 years’ global experience with agencies such as US FDA, Brazil ANVISA, Mexico COFEPRIS, NMPA (China FDA), S Korea Ministry of Food and Drug Safety, Hong Kong, Malaysia, Health Canada, Australia TGA, Thailand FDA, Japan PMDA, EMA, Saudi FDA, CDSCO of India and several Notified Bodies, e.g., BSI, DEKRA, Medcert, and TÜV SÜD. As a former tenured Professor/Chairman in academia, IRB member and clinical investigator, he understands the role of a PI as a sponsor-investigator in clinical trials. He has published over 100 manuscripts. He was inducted as a Fellow of the American Heart Association in 1995. He previously accepted a 4-year appointment from the United States Department of Health & Human Services to serve as the Industry Representative on the FDA’s General Hospital and Personal Use Devices Advisory Committee in FDA’s Center for Devices and Radiological Health (CDRH). He is certified as a Lead Auditor for Quality Management Systems ISO13485 and holds certificates for Design Control, Risk Management, Six Sigma, and CAPA. Dr. David R Rutledge was formerly a Director with Abbott Medical Devices in Global Clinical Research and then Global Regulatory Operations. He has managed budgets up to $23.3 million. He is currently President & CEO at Global Strategic Solutions, LLC within the Biotech, Med Device, and Pharma industries in the areas of Clinical Investigations, Clinical Evaluations, Clinical Risk Management, Surveys, PMS/PMCF, SSCP, PSUR, R&D, Meta-Analyses, Big Data, Artificial Intelligence, and Biocompatibility.

Dr. Ibim Tariah earned his PhD in Materials Science the University of Manchester, U.K. Dr. Tariah has over 30 years experience in the medical device industry, including 21 years at BSI. In Dr. Tariah's role of VP of EU MDR/IVDR Consulting Services at R&Q, he provides leadership, strategic advisement and implementation expertise to R&Q's consulting team and medical device clients. Prior to R&Q in his role of Technical Director of Medical Devices for BSI Americas, Dr. Tariah was part of the BSI Americas leadership team responsible for transitioning from MDD to MDR certification. Dr. Tariah recognized the significant challenges in implementation of the EU MDR. He created and led customized MDD and MDR workshops for clients and industry, and spoke on behalf of the notified body at global conferences and events. At BSI, Dr. Tariah also provided expertise in innovative vascular, orthopedic, dental, and other long term implantable devices for clients needing technical documentation assessment and reviews in compliance with the MDD and MDR. Dr. Tariah acted as a client liaison to Regulatory Authorities including MHRA (UK), European Medicines Agency (EMA),and Medical Products Agency (Sweden). Prior to his role at BSI, Dr. Tariah led global organizations through successful product development. His vast experience includes Regulatory knowledge of combination devices incorporating biologics, drugs and drug-biologics along with Quality Assessment of Medical Devices.