- Our company was established to enable medical companies in Europe, North American, Asia, and other regions to release medical devices, medical software, and IVDs in the market in Japan.- Our services cover consultations and paper works regarding regulatory affairs, quality assurance, and good vigilance practices in any medical fields.- Human Rights and Ethics of how to use IT and Artificial Intelligence are of our great concerns because as well as nuclear, chemical, and biological weapons IT and AI also would be one of menances leading to jeopadizing the survival of the mankind. Professional Profile: * Highly experienced professional with regulatory affairs, quality assurances, and good vigilance practices of medical devices and IVDs in Japan (for 15 years) with extensive experience in technical R&D background (for 30 years). * Regulatory Affairs for years' experiences in medical devices and IVDs fields: registered and obtained their approvals/certificates in collaboration with related entities, such as RAQA, R&D, marketing, sales departments, plants and other stakeholders in overseas, as working with PMDA, MHLW, and the notified body, based on the PMD Act. Consequently obtained many types of reimbursements of these devices from MHLW.