EU Policy and Regulatory Updates - January / February 2026
EU Policy and Regulatory Updates
EU Policy and Regulatory Updates
The Avicenna Alliance ispleased to announce the publication of the 5th Release of the Avicenna …
The medical device industry is increasingly adopting computational modeling and simulation (CM&S) throughout the product life cycle—from early-stage design and prototyping to regulatory submissions and post-market performance evaluation. A key challenge across all these applications is establishing whether a model is sufficiently credible to support (regulatory) decision-making. The ASME V&V 40 standard, published in 2018, introduced a risk-based framework for assessing model credibility and has gained broad acceptance across the industry.
The Avicenna Alliance is delighted to welcome the British Standards Institution (BSI) – …
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