AMDS 2018 Workshop Video Library

Topic: Software Design and Implementation for Today's FDA/CE - MDR Submission

At the American Medical Device Summit on October 25, 2018, Bill Stamm, our VP of Software Engineering Services, conducted a workshop:


  • Quality, Cybersecurity & Safety, the cornerstones of the product submissions for 2018...and always!
  • Developing testable requirements and code. Design and code for testing and traceability, and eliminate bugs along the way.
  • Documentation and deliverables—shortfalls and pitfalls: How to navigate around them and create a submission with the right traceability and objective evidence.
  • Cost effectiveness: It is possible to make a better product and reduce costs at the same time by understanding the best practices.
  • How to implement best practices into your design process, or update your current product roadmap and design it for the current environment.

Below is a video of the entire presentation. We also broke the video into 16 short clips to make it easier to listen to a particular topic of interest.


Video thumbnail
Software Design and Implementation for
Today’s FDA/CE - MDR Submission (33:16)
Video thumbnail Part 1: Introduction to Workshop (2:43) Video thumbnail
Part 2: Intended Use and Product Requirements (1:54)
Video thumbnail
Part 3: System Design, Layout and Risk (2:31)
Video thumbnail
Part 4: Level of Concern, Risk Mitigation & Software Req’ts. (2:03)
Video thumbnail Part 5: Software Architecture & Design (1:55) Video thumbnail Part 6: Coding Standards (1:35) Video thumbnail Part 7: Testable Code & Code Complexity (2:07) Video thumbnail Part 8: USA vs Europe (2:29)
Video thumbnail Part 9: Static Analysis & Code Review Reports (1:34) Video thumbnail Part 10: Traceability & the “I” in IV&V (2:21) Video thumbnail Part 11: Quality & Return on Investment (2:21) Video thumbnail Part 12: Bugs vs Cost (2:21)
Video thumbnail Part 13: Cybersecurity (2:25) Video thumbnail Part 14: Reducing Costs & Achieving ROI (2:21) Video thumbnail Part 15: Documentation & Deliverables – “Doing It Right” (2:02) Video thumbnail Part 16: Bill’s Final Thoughts (1:34)


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