Risk Management Services
We address patient risk early and often, saving you time and money. Risk management is baked into our ISO 14971 and IEC 62304 compliant Agile approach. By addressing risk early and often, we enable our product teams to focus on the highest-risk areas throughout the process, thereby saving time and money. Whether we’re evaluating use error inputs from human factors, drawing from cybersecurity risk analysis, analyzing hardware and firmware components, or applying software segregation techniques, we’re ensuring clarity, regulatory compliance and – most important of all – patient safety.
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