In this free webinar, learn how medical devices benefit from modern digital validation strategies. Attendees will learn how digital validation builds confidence and removes redundancy. The featured ...

Structural barriers, including reliance on predicate-based pathways and misaligned financial incentives, discourage rigorous evaluation of AI tools.

Countless Warning Letters or FDA 483s include the following violations: “Failure to ensure, where the results of a process cannot be fully verified by subsequent inspection and test, that the process ...

SimuTech Group announces the publication of a new chapter co-authored by two of its principal engineers, Mark Goodin and ...

Oracle Health has introduced a new three-tier validation framework for medical devices that it says standardizes approaches to validating connectivity, functionality and workflow alignment and will ...

Inadequate process validation related to medical devices was cited more than 600 times by the US Food and Drug Administration (FDA) in 2013. In efforts to meet the agency’s standards, device ...

We’ve all heard process validation horror stories. Validations can take years. Creeping elegance can take over. Product launches can be stopped in their tracks. When implemented correctly, however, ...

AI Medical Device Security now hinges on post-market monitoring, SBOM discipline, model drift controls, and clear update ...

To simplify and enhance medical device connectivity across health systems, Oracle Health has launched the Oracle Health Device Validation Program for the U.S.—establishing a standardized approach to ...