The FDA Group's CEO, Nick Capman sits down with Brian Dense, a medical device consultant with over 30 years of experience across several parts of the industry, to discuss risk management for medical devices, emphasizing key points such as:
» The importance of risk management in the medical device industry as it forms the basis of regulations and ensures safe and cost-effective products.
»Different markets, including the European Union, Canada, and the United States, and their specific regulatory requirements.
» The primary standard for risk management, ISO 14971, with the 2019 version designed to align with the EU MDR regulation.
» The significance of addressing the EU's 15 General Safety and Performance Requirements (GSPRs) and including usability in risk management.
» Risk acceptability determination, using ISO 14971's standard ranking system and evaluating products based on safety rather than cost.
» The importance of usability in risk management, even for lower-class devices, and its integration with design history and risk management files.
» The role of FMEA in assessing risk by identifying potential failure modes, their effects, and their probability of occurrence.
» The value of involving a diverse team with backgrounds in engineering, manufacturing, quality, and marketing when conducting FMEA.
» The use of process FMEA to evaluate each step in the manufacturing process and identify potential failures impacting the device's performance or safety.
» The importance of reading and understanding ISO 14971 and ISO/TR 24971, as well as the EU MDR regulation and its GSPRs for those entering the European market.
Brian's medical device experience covers a diverse range of products from dental instruments and diagnostic equipment to orthopedics, spine, contact lenses, and urological products. His extensive background spans various company sizes, including working with two startups and three large conglomerate corporations.
Over the course of his career, Brian has developed expertise in several areas of the medical device sector, such as orthopedics and spine, as well as other specialized fields. In the past 13 years, he has transitioned to consulting, where he has been connected with The FDA group for seven years.
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