Medical Device Risk Assessments

Today more than ever parenteral therapeutics are self-administered utilizing an associated medical device. It is imperative that the clinical benefit-risk assessment incorporate the drug product and the delivery system as an integrated entity:

  • Human Factors Considerations – Understanding how the patient or Health Care Provider interact with the device.

  • FMEA Assessments – appropriately characterizing the severity rating associated with the failure mode.

  • Residual Risk Assessment – The totality of the potential device risk to patient safety should inform the penultimate Benefit-Risk evaluation.

  • Ultimate Benefit-Risk Assessment – considering the implications of a device failure with the drug product’s pharmacology and the intended patient population.

  • Small Parts Safety and Device Safety Labeling – Identifying special hazards associated with device use or storage.

Assessing and mitigating device-related risks early in development is critical to facilitate successful clinical application.

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