FDA Cranks up Pressure for Modeling and Simulation
In November 2023, the FDA released new guidance on assessing the credibility of computational modeling and simulation (CM&S) in medical device submissions. This guidance underscores the agency’s commitment to advancing digital strategies and driving the broader adoption of... read More....
0
22
Oct 2025
In Silico Design Verification Testing of Medical Devices
V&V 40 Forum: Regulatory-Grade CM&S Evidence Generation Using ASME V&V 40 October 2, 2025 | 9:00 AM – 4:00 PM EST | In-person and Online Join us for a one-day hybrid event that brings together ASME V&V 40 subcommittee members, regulatory experts, and... read More....
0
16
Sep 2025
At the Needle Point: The Role of Materials in a Coronavirus Vaccine
The development of a vaccine for the novel coronavirus SARS-CoV-2 has captured—perhaps uniquely—the attention of a global audience of scientists, medical doctors, politicians, and the general public. However, identifying a viable vaccine candidate is only one of the first, of... read More....
0
11
Aug 2020
