Risqium Ltd

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Cambridge, GB

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What is Risqium Ltd?

Risqium helps medical device and health-tech teams to find and manage risk in their products at an early stage, when it is cheapest and easiest to mitigate. Risk management is too often left until late in the development process and treated as a tick-box exercise done simply to satisfy a regulator. At Risqium we believe risk management should be part of the design process from the earliest stages of the project. Starting early allows teams to build safer products, avoid costly rework and reach the market with increased confidence. Our platform, risqMap, combines the power of AI with real-world regulatory data and standardized terminologies, allowing users to rapidly identify potential hazards and failure modes. With risqMap you can: • Quickly identify hazards that are relevant to your product • Build a Preliminary Hazard Analysis (PHA) in a fraction of the usual time • Produce structured Risk Analysis documentation to support ISO 14971 and NHS clinical safety (DCB0129) requirements, which can be easily exported to Excel • Work together as a team to iterate and develop Risk Analysis for your products risqMap supports expert human judgement; it doesn't replace it with AI. You stay in control of every decision, and risqMap makes sure you start from a well-informed position. Whether you're a start-up taking your first product to market or an established manufacturer looking to streamline your risk process, risqMap gets your development teams engaged with risk management from day one. Find out more at risqium.com