Medical devices - In silico technologies - Part 2: Credibility assessment of first-principles based methods
Abstract
This document specifies principles and general requirements for establishing the credibility of computational modeling 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 modeling 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.
Begin
2026-02-11
Planned document number
DIN EN IEC 63719-2
Project number
02233714
