Global Medical Device Podcast Powered By Greenlight.guru

In this episode, Sandra Rodriguez, an analyst at Axendia, dives deep into the complexities of Computer Systems Validation (CSV) versus Computer Software Assurance (CSA) in the MedTech sector. She discusses the FDA's draft guidance from September 2022, the industry's response, and the practical applications of it all. The conversation also covers the evolution of software validation processes, the cost of system implementation, and the importance of critical thinking in Quality System Regulations. The impact of AI on Quality Assurance, the changing dynamics of the CSA Modern Validation, and the role of Software Assurance in the life sciences industry are also discussed.Some of the highlights of today’s show include:The evolution of software validation processes, the cost of implementing a system in the life sciences industry, and the role of critical thinking in Quality System Regulations.FDA's draft guidance from September 2022, the industry's response, and its practical implementationsThe cultural shift