Computational Modeling and Simulation of Medical Devices
This open-access book showcases the remarkable progress of computational modeling and simulation (CM&S) in medical device development over the last twenty years. It examines both the opportunities and the challenges associated with current CM&S applications, while exploring new and emerging directions for the field.
The publication aims to support the continued credible adoption of CM&S within the regulated medical device environment, recognizing its potential to facilitate device development, commercialization, and regulatory assessment, ultimately improving patient care worldwide. It also presents the latest advances enabling the integration of computational modeling into product development and regulatory decision-making, including an overview of relevant policies, standards, and regulatory guidance. Throughout the book, leading experts from industry contribute practical examples that illustrate the application of CM&S across a range of real-world scenarios.
Key features include:
- An introduction to the core scientific principles of verification, validation, and uncertainty quantification (VVUQ), providing readers with a solid foundation.
- Insights and lessons learned from the implementation of CM&S across multiple regulated industries.
- Medical device case studies, together with perspectives on future applications, including clinical use cases and artificial intelligence/machine learning (AI/ML).
