May 15, 2024

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

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