Hilary Baldwin, VP of Regulatory & Quality at SimBioSys, highlights how Qualio’s real-time assembly of risks, traceability matrices, and documents dramatically reduces regulatory workload. Instead of compiling everything at the end, Qualio provides immediate access to these critical compliance elements, saving months of work. For SimBioSys, a life science start-up developing an innovative Class II SaMD platform in oncology, this streamlined approach has been invaluable in managing regulatory demands efficiently and accelerating their development process with confidence and precision.

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