[September 29 Free Seminar] QMS and Regulatory Submission for SaMD and Program Medical Devices - Explaining the Practicalities from Determining Medical Device Applicability to QMS Investigation.
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The advancement of AI and digital health has led to a rapid increase in the entry of Software as a Medical Device (SaMD), including diagnostic support AI and therapeutic applications. On the other hand, there are many software-specific issues, from the initial judgment of whether it qualifies as a medical device to drug approval applications and the establishment and compliance investigation of Quality Management Systems (QMS). Businesses originating from IT and software companies often find themselves at a standstill, unsure of where to start.
In this seminar, Yuki Hasegawa, who has experience in regulatory affairs, quality assurance, and obtaining business licenses at several foreign medical device and in vitro diagnostic manufacturers, and who currently provides extensive support for the establishment of regulatory and quality systems for medical device and in vitro diagnostic manufacturers, will speak. The seminar will systematically explain the definition and classification of program medical devices, the thought process for judgments based on medical device applicability guidelines, specific points related to SaMD in approval and certification applications, and the perspectives confirmed during QMS compliance investigations.

| Date and time | Tuesday, Sep 29, 2026 02:00 PM ~ 03:30 PM |
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| Entry fee | Free |
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