Launch of ISO-IEC JWG 14 to Advance In Silico Standards for Medical Devices
On 03 February 2026, following the successful approval of the new work item in 2025, the newly established ISO-IEC Joint Working Group 14 (JWG 14) has officially commenced its activities.
The joint ISO-IEC working group has been formed to develop the IEC 63719 series, addressing standardization needs for in silico technologies in medical devices. The project is being led under IEC with strong cross-organizational collaboration.
The newly launched initiative includes the following deliverables:
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IEC TR 63719-1 ED1
Medical devices – In silico technologies – Part 1: Terminology and context -
IEC TR 63719-2 ED2
Medical devices – In silico technologies – Part 2: Credibility assessment of first-principles based methods
One of the project’s co-conveners is Marc Horner (Ansys), reflecting strong alignment with established verification and validation methodologies. In the JWG 14 the in silico medicine community is duly represented by the VPH Society, who has an official chair in the group.
The IEC 63719 series is expected to:
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Establish harmonized terminology for in silico technologies in medical devices
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Provide structured guidance on credibility assessment of first-principles computational methods
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Support regulatory acceptance of model-informed evidence
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Strengthen international alignment with existing risk-based verification and validation frameworks
The launch of ISO-IEC JWG 14 represents a significant milestone in advancing global standardization for computational modeling in healthcare.
Further updates will be shared as the work progresses.
