Sharing Experiences for Creation of Sufficient Clinical Data

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.

Dr. Krishna Medasani is Currently the Clinical Safety Physician for Natus Clinical Affairs Team.

Dr. Medasani brings over 12 years of Medical Device experience. Most recently, Dr. Medasani held the role of Principal Scientist and Clinical Risk Management and Clinical Safety Manager at Abbott Laboratories.

Dr. Medasani holds an MD from Gulbarga University, Residency in Internal Medicine from Osmania General Hospital, Internship from North Western Memorial Hospital, Chicago, IL, MS in Regulatory and Quality Management Sciences from the University of Southern California, Los Angeles and an Executive Health Care MBA from the University of California, Irvine.

Presently Dr. Medasani is responsible for Clinical Evaluations, Post Market Surveillance, and Risk Assessment for Class III medical devices in Natus Neuro Portfolio and Class IIb devices in Newborn Care.

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. Julien Senac is currently Global Director of the IVD Focus Team at TÜV SÜD, overlooking the development of IVD field and in particular IVDR. Prior to this, he has many years of experience with a certification body, where he participated to the preparation of IVDR designation, and performed Design Dossier assessment of in vitro diagnostic devices. Dr Senac has a Ph.D. in Molecular and Human Genetics from Baylor College of Medicine (Houston, TX) and more than 10 years of experience in biomedical research. He worked in top research/medical institutions in the United States such as Mayo Clinic and the National Institutes of Health. Dr Senac has also participated to the development of multiple biotech start-up companies in oncology and gene therapy.

Dr. Suarez-Cuervo has been the Medical Writer for ConMed Corporation for the last two years. During this time, she has led the transition of all clinical documentation from the MDD to MDR and has started the implementation of PMCF studies for all devices.

Dr. Suarez-Cuervo is trained in medicine and Internal Medicine, she is an expert in clinical trials, evidence-based medicine, and methodology. Before joining ConMed, she worked for ten years in the Johns Hopkins Evidence Based Practice Center, where she successfully collaborated with experts from multiple areas, conducted multiple systematic reviews, meta-analysis and technical briefs, published several peer reviewed manuscripts and was part of the Cochrane Collaboration.

Prior to this, she trained and worked in the Comprehensive Cancer Center at the University of Alabama at Birmingham; she worked in all facets of basic, translational, clinical research and clinical trials in cancer, where she designed and developed study protocols, managed and analyzed data, and cared for patients in clinical trials.

Dr. Suarez-Cuervo has co-authored 40 peer reviewed publications, 50 Technical Briefs for the Patient Centered Outcomes Research Institute (PCORI), six systematic reviews for the Agency of Health Related Quality (AHRQ), and has completed twelve Clinical Evaluation Reports for ConMed in compliance to new MDR guidelines.

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.