Clarification of clinical significance is very important in the development of SaMDs (Software as a Medical Device) that have become active in recent years.
This whitepaper summarizes the items that should be considered when clarifying the clinical significance based on the “Guidelines of Determining Whether Software is Classified as a Medical Device” issued by the Ministry of Health, Labour and Welfare (MHLW) of Japan in 2021.
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We provide comprehensive, end‑to‑end clinical development support, with imaging at its core.
With more than 20 years of experience, our team of imaging specialists in Japan and around the world tackles the complex challenges of imaging evaluation in pharmaceutical and medical device development. We deliver optimal, project‑specific solutions for each client.