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 ...

Laboratory-based design verification testing (DVT) of combination products and medical devices must be performed to demonstrate that the device meets the performance requirements that were set in the ...

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

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 ...

Medical device equipment manufacturers work in an environment where product quality isn't just a competitive advantage, it's a regulatory necessity with direct implications for patient safety. As ...

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

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 ...

Validation ensures that a part will operate correctly in end-user applications. Design validation is the task of testing a part or a system adequately to ensure that all parts or systems manufactured ...

Researchers found that among 1,357 FDA-cleared or approved AI/ML-enabled medical devices, only 34 were linked to registered ...