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 Services, conducted a workshop:

SOFTWARE DESIGN AND IMPLEMENTATION FOR TODAY’S FDA/CE - MDR SUBMISSION

  • 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)

Tweets

News & Events

  • EXHIBITING AT THE AMERICAN MEDICAL DEVICE SUMMIT
    This October, we’ll be exhibiting, engaging attendees on software topics and conducting a workshop at AMDS in Chicago READ MORE >

  • SOFTWARE SERVICES DEVELOPS SOFTWARE TO MEASURE PAIN
    Together with partner AlgometRx, we have been working on a pupilometer that measures a patient’s pain level READ MORE >

  • SOFTWARE SERVICES RECORDED A MEDICAL DEVICE PODCAST!
    Bill & Rafael of our Software Services Group discussed how to validate software for medical device companies READ MORE >

Contact Info

General Digital Corporation
8 Nutmeg Road South
South Windsor, CT 06074
United States of America


860.282.2900 (Local & International)
800.952.2535 (Toll-Free U.S. & Canada)


ISO 9001:2015 QMS Certified
ISO 9001:2015 QMS Mark