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Computational Models used for Evaluating Medical Devices in Regulatory Submissions

Computational Models used for Evaluating Medical Devices in Regulatory Submissions

Wednesday, October 21, 2020 (1:00 PM - 2:00 PM) (EDT)

Description

Computational models are increasingly utilized in medical device regulatory submissions thanks to specific efforts by the FDA over the last decade to clarify expectations and benefits of the use of this tool. This included the 2019 official recognition of the consensus standard, ASME V&V40-2018 Assessing Credibility of Computational Modeling Through Verification and Validation: Application to Medical Devices. This document provides guidance for assessing the relevance and adequacy of verification and validation (V&V) activities for establishing model credibility, and its implementation within industry is expanding rapidly. In order to effectively use evidence from computational models in regulatory submissions, understanding and applying these methods for evaluating computational models is critical. This presentation will include a discussion of the document’s structure and content and provide attendees with useful insight into how the described methods can be used by their organization. 

Speakers

Andrew Rau

Dr. Steve Kreuzer

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Event Contact
Bette McKenzie
617-201-0074
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