The Avicenna Alliance is joining the IEC TC 62& ISO/TC 276/WG5 Committees

To facilitate and accelerate the adoption of in silico methods for testing new products and generating digital evidence for the regulatory approval process, adding reference to Computational Modeling and Simulation (CM&S) and/or the ASME VVUQ 40 in the ISO standards is undoubtedly reinforcing confidence in this approach.

Building on its partnerships with standards organisations DIN and ASME, the Avicenna Alliance will contribute to the IEC TC 62 Medical equipment, software, and systems & ISO/TC 276/WG 5 Data Processing and Integration committees by bringing the expertise of its member to this important community with the aim of increasing the number of ISO standards making reference to CM&S. We were delighted to see the publication in July 2023 of ISO 21535 and ISO 21536 referring to ASME VVUQ40.

Similarly, the consideration and adoption of in silico methods were encouraged by the publication of ISO 20691 (Requirements for data formatting and description in the life sciences: https://www.iso.org/standard/68848.html), published in November 2022, as well as of ISO/TS 9491-1 (Predictive computational models in personalized medicine research - Part 1: Constructing, verifying and validating models: https://www.iso.org/standard/83516.html), published in June 2023. We are joining forces to multiply in silico references in ISO standards for orthopedic and all other healthcare applications and therefore facilitate the widespread adoption of in silico methods.

We are very grateful for Martin Golebiewski’s fantastic guidance on this important initiative in collaboration with VPHi and InSilicoWorld.