Three months in, most medical device manufacturers have completed their initial gap assessments — but the harder work is only beginning. The QMSR did more than rename legacy QSR requirements. It ...

Models are a simplification of reality that can be compared to maps. Road maps indicate certain aspects of reality (for example, roads of a certain size) and not others (for example, sewer lines, ...

Announcing a new article publication for BIO Integration journal. The development of a comprehensive regulatory model for medical devices is essential to ensure the safety, efficacy, and quality of ...

As AI capabilities accelerate, governments are adopting markedly different approaches to governance - ranging from binding statute and sector-led oversight to decentralised regulatory models and ...