136 - Systems Engineering for Combination Products, User Needs, Design Inputs, Design Changes, Risk Management Files and Avoiding HUGE Traceability Mistakes with Chuck Ventura

On this episode I was joined by Chuck Ventura, Founder of Ventura Solutions and CEO of HemoTek. On this episode Chuck walks through: 00:29 Design Changes When No DHF Exists 03:30 Challenges and Strategies in Document Management 04:49 Improving Design Inputs and Risk Management 21:37 Leveraging Tools for Better Traceability and Compliance Charles Ventura is the Founder of Ventura Solutions and CEO of HemoTek. Chuck is a leader in the Medical Device & Combination Products space with successful experience in Commercialization, R&D, Project Management, and Manufacturing Support. https://ventura-solutions.com/