Computational Modeling and Simulation of Medical Devices

Beschreibung

This open access book reflects the growth of computational modeling and simulation (CM&S) in support of medical device development over the past two decades, identifies the opportunities and challenges associated with contemporary CM&S applications, and highlights emerging areas for CM&S in medical devices. The authors provide a springboard for the continued credible use of CM&S in this regulated space, with the belief that such uses will contribute to the development, commercialization, and regulatory review of devices that will positively impact patient health around the globe. Content includes recent developments supporting the use of computational modeling as part of device development and regulatory review, including an overview of governmental policies, relevant standards, and guidance documents. A series of industry-specific examples are also provided by a number of recognized subject-matter experts.

• Provides the fundamental scientific principles of verification, validation, and uncertainty quantification (VVUQ) so that the reader has a baseline understanding;
• Summarizes experience from various sectors regarding the development of CM&S for various regulated industries;
• Includes case studies in the medical device industry and future perspectives on clinical applications and AI/ML;
• This book is open access, which means that you have free and unlimited access.

This open access book reflects the growth of computational modeling and simulation (CM&S) in support of medical device development over the past two decades, identifies the opportunities and challenges associated with contemporary CM&S applications, and highlights emerging areas for CM&S in medical devices. The authors provide a springboard for the continued credible use of CM&S in this regulated space, with the belief that such uses will contribute to the development, commercialization, and regulatory review of devices that will positively impact patient health around the globe. Content includes recent developments supporting the use of computational modeling as part of device development and regulatory review, including an overview of governmental policies, relevant standards, and guidance documents. A series of industry-specific examples are also provided by a number of recognized subject-matter experts.

• Provides the fundamental scientific principles of verification, validation, and uncertainty quantification (VVUQ) so that the reader has a baseline understanding;
• Summarizes experience from various sectors regarding the development of CM&S for various regulated industries;
• Includes case studies in the medical device industry and future perspectives on clinical applications and AI/ML;
• This book is open access, which means that you have free and unlimited access.

Autor*in

Marc Horner

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medical device regulatory review computational models for medical device development VVUQ medical devices CM&S regulatory submissions VVUQ best practices medical Open Access

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