Drug and Device Risk Assessments
Minimize risks by identifying concerns before your products hit the market.
Building safer products, faster
Med Safety Board experts specialize in proactive risk assessments to help you identify potential use-related errors and safety concerns before your product reaches the market. Conducted during pre- and postmarket stages, our assessments help identify potential errors using use-related risk analysis (URRA) and failure mode and effects analysis (FMEA). We work collaboratively to pinpoint risk areas in the use process and develop strategies to mitigate those risks before regulatory submission and market approval.
Our Approach
At Med Safety Board, our comprehensive risk assessment process begins with a thorough product profile review, where we gather key product information such as prototypes, samples, instructions for use, labeling, and manuals. We then conduct an error search by reviewing ECRI and the ISMP PSO event databases, device evaluation reports, and newsletters to uncover potential safety gaps related to the product or similar devices. Next, we identify use-process steps by describing product settings as well as how the product will be used by end-users. Our team of safety experts and human factors engineers performs a detailed URRA, identifying potential error scenarios, evaluating the risk of harm, and recommending mitigation strategies. Finally, we deliver a comprehensive report summarizing our findings and providing actionable recommendations to enhance product safety and usability.
Our Methodology
Failure Mode and Effects Analysis (FMEA)
FMEA identifies potential design flaws by analyzing failure modes, consequences, and risks. It predicts human errors and examines processes to assess impact. The goal is to simulate real-world use, uncover problem areas, and provide actions to mitigate likely errors before they occur.
Human Factors and Usability Testing
By assessing how users interact with medication systems, our experts identify potential risks, ensuring that design, labeling, and instructions are user-friendly. This process helps reduce errors and enhances overall patient safety and healthcare outcomes.
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More Ways We Help
Trademark Name and Safety Testing
Proactively evaluate pharmaceutical brand names to identify look-alike and sound-alike risks, minimizing medication errors and confusion.
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