FDA-Seminar.pdf (3.3 MB)
FDA Seminar on Computational Modeling for 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 2017-05-18, 15:32 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
2. Assessing Credibility of Computational Modeling through Verification and Validation
3. Critical Thinking
1. Reporting Computational Modeling Studies in Medical Device Submissions
2. Assessing Credibility of Computational Modeling through Verification and Validation
3. Critical Thinking