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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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

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Show Notes

On this episode I was joined by Chuck Ventura, Founder of Ventura Solutions and CEO of HemoTek. On this episode Chuck walks through:

Timestamps

  • 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.

ventura-solutions.com

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