Establishing Credibility of Medical Device Modeling & Simulation

The U.S. Federal Drug Administration (FDA), has actively advocated for expanding the use of Computer Modeling & Simulation (CM&S) as valid evidence to support the safety and efficacy of medical devices for regulatory submission. As part of this process, Medical device companies need to establish credibility of the CM&S evidence that they create.

The ASME Verification and Validation standard (V&V40) provides a framework to establish credibility of CM&S evidence.  Following the standard is challenging, as it requires multiple teams to contribute and adhere to an elaborate framework that requires strict record keeping.

Watch this replay to discover:

• Robust CM&S  technology and processes that encapsulates the entire V&V40 framework
• How to use a web-based template to guide multiple teams through the V&V40 framework, ensure data management, and generate reports while maintaining complete traceability
• The benefits of using the 3DEXPERIENCE platform to deploy, democratize, globally enforce V&V40 compliance