How Freyr Helped an AI-based SaMD Developer specializing in Microscopy Analysis with PMPF

An India-based SaMD company specializing in AI-powered Microscopic Analysis sought Freyr’s expertise to develop a comprehensive Post-Market Performance Follow-up (PMPF) plan for its CE-certified IVD analyzers under EU IVDR 2017/746. The devices being AI SaMD IVD devices added to the complexity. Ensuring compliance with evolving Regulatory expectations required a structured approach to documenting PMPF activities, defining study objectives, and aligning with relevant Regulatory guidelines. Discover how Freyr’s expertise in PMPF planning helped the client establish a comprehensive and compliant PMPF plan, ensuring a well-documented rationale, structured timelines, and seamless alignment with Regulatory requirements.

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