ISO/PWI 63691-2

Medical devices — In silico technologies — Part 2: Credibility assessment of first-principles based methods ISO/PWI 63691-2

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.