IEC/AWI 63739-2

A working group has prepared a draft.

Abstract

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.