01 / Reading Guide
Reading Guide
Who this book is for
For graduate students and engineers studying how computational evidence supports medical device development. The book connects numerical accuracy with experimental comparison and the intended use of a model. It is useful after learning how to run a simulation, when the central question becomes what the calculation can justify and how the consequences of an incorrect prediction should shape the evidence required.
Prerequisites
Engineering mechanics or transport, numerical modelling and introductory probability or statistics. Experience with a simulation package and a biomedical design project helps make the credibility questions concrete.
What it covers
Foundational chapters treat verification, validation and uncertainty quantification before discussing credibility frameworks and regulatory perspectives. Device-related examples span multiple engineering settings, including structural and cardiovascular applications. Contributions from different sectors help show which modelling principles are general and which depend on a particular context of use.
How to use it
Write the engineering question, context of use and quantity of interest before building a model. Separate code or numerical verification from comparison with physical observations. List uncertain inputs, model-form assumptions and the experiments available for validation, then explain whether they cover the conditions of the proposed use. Compare a case study’s credibility argument with your own model rather than copying its checklist. Record what evidence would change the model or narrow its intended application.
Edition and sources
Springer provides the complete first edition, published July 2026, ebook ISBN 9783032091802. It is an open-access edited engineering reference with chapter-specific attribution. Its discussions of standards and regulatory practice should be matched to the exact versions and jurisdictions relevant to a project.
