MAPI provides an "AI CRO" service that offers end-to-end support for AI medical devices, from development through marketing approval. From PMDA consultations, the design and conduct of performance evaluation studies, and QMS establishment to regulatory submissions, our physicians and regulatory specialists work side by side with AI startups and medical device manufacturers to bring Software as a Medical Device (SaMD) into real-world use.
We support everything from formulating regulatory strategies for Class II–IV software medical devices to preparing for and attending PMDA consultations (strategy consultations and face-to-face advice). By designing strategies with the approval review in mind from the earliest stages of development, we enable efficient development without rework.
We provide full support for the performance evaluation studies specific to AI medical devices, from study design to report writing. We handle highly specialized work such as image collection and processing, building and operating reader study systems, and statistical analysis. With an in-house ethics review board enabling rapid review, we ensure data reliability in line with the 0929 Notification while keeping costs appropriately managed.
We support building the QMS required for SaMD, preparing approval and certification applications, and establishing post-market safety management system. For AI startups, university spin-offs, and other companies making their first medical device application, our physicians and regulatory specialists work alongside you to drive the practical work forward.
