FDA-Seminar.pdf (3.3 MB)
FDA Seminar on V&V for Computational Modeling of Medical Devices
Version 3 2017-08-08, 11:17
Version 2 2017-08-08, 11:16
Version 1 2017-05-18, 15:32
presentation
posted on 2017-08-08, 11:17 authored by Tina MorrisonTina Morrison, Leonardo Angelone, Matthew Myers, Joshua Soneson, Quanzeng Wang, Jason Weaver, Prasanna Hariharan, ASME V&V40, Mehul Dharia, Markus ReitererThis presentation was delivered at the 3rd Annual BMES/FDA Frontiers in Medical Devices Conference. This presentation covers three key topics:
1. Reporting Computational Modeling Studies in Medical Device Submissions, FDA Guidance
2. Assessing Credibility of Computational Modeling through Verification and Validation, ASME V&V40 Draft Standard
3. Critical Thinking
1. Reporting Computational Modeling Studies in Medical Device Submissions, FDA Guidance
2. Assessing Credibility of Computational Modeling through Verification and Validation, ASME V&V40 Draft Standard
3. Critical Thinking
