##  [How Freyr Helped an AI-based SaMD Developer specializing in Microscopy Analysis with PMPF](/case-studies/how-freyr-helped-an-ai-based-samd-developer-specializing-in-microscopy-analysis-with-pmpf) 

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- [Digital Health](/case-studies-main-categories/digital-health)





[EMA](/case-studies-heath-authority/ema)

 

 ![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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