Tag Archives: biological evaluation

Structural Analysis

Addressing ‘Equivocal’ Toxicological Assessment Results with Risk Mitigation Strategies

By Kim Ehman, Ph.D., Sandi Schaible, Sherry Parker, Ph.D.
Structural Analysis

Intensive chemistry requirements are creating massive data sets of chemicals, all of which need to be assessed for biological safety. This deluge of data is making equivocal results far more common than ever before. Fortunately, manufacturers can take steps to mitigate risk and support the safety of their products.

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Biological Evaluation of Medical Devices

By Jan Peeters, Paul Malinovski

The biological safety of a device is established for both short-term (acute) and longtime (chronic) safety risks to patients and device users. Medical device manufacturers must investigate their devices thoroughly to meet these expectations to receive approval to market their devices.

The biological safety of a device is established for both short-term (acute) and longtime (chronic) safety risks to patients and device users. Medical device manufacturers must investigate their devices thoroughly to meet these expectations to receive approval to market their devices.

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