068 - Benefit/Risk Ratios, PRRC, and Mythical Medical with David Rutledge

On this episode I was joined by David Rutledge, author of Mythical Medical and CEO of Global Strategic Solutions. David Discusses: · His book Mythical Medical · Benefit (As part of Benefit/Risk) · PRRC Role and EU MDR David R Rutledge, Pharm.D., FCCP, FAHA is a results-oriented consultant for clinical evaluation and investigation, 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. 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. He qualified as an EU Person Responsible for Regulatory Compliance (PRRC)