ISO/PWI 63691-2

Medical devices — In silico technologies — Part 2: Credibility assessment of first-principles based methods

Scope

This document specifies principles and general requirements for establishing the credibility of computational modelling and simulations used in the field of medical devices. It primarily covers first-principles based modelling approaches*.
This document applies to in silico technologies used in the design, development, evaluation, and lifecycle management of medical devices, including their use in the regulatory decision-making process.
The document describes a risk-based framework evaluating the credibility of computational modelling and simulation activities for a specific context of use.
This document does not address requirements for data-driven or statistical models or the clinical evaluation of medical devices outside the use of computational models.
*First-principles based models refer to approaches that are derived from a fundamental understanding of physical, chemical, or biological phenomena using established principles to describe a process. See “Medical devices – In silico technologies – Part 1: Terminology and context” for detailed information.