About Save Medical


Save Medical is a Japanese company which is engaged in development of Software as a Medial Device (SaMD) products, mainly Digital Therapeutics (DTx). We develop multiple product pipelines mainly with major Japanese Corporations, especially pharmaceutical companies. We are one of the first companies to develop SaMD
products in Japan, and went under clinical trial.


Services for Overseas customers


Utilizing our experience, knowhow and human resource as one of the pioneers in this field, we provide services related to medical device for overseas customers which plan to enter the Japanese market.


(1) Biz Dev support

Our core members have 10 +  years experience of business development in the SaMD and digital health field. Using our unique experience, we are able to guide overseas customers to the optimal and quickest direction for business development in Japan. We are able to connect you to major Japanese corporations for your business collaboration.


(2) Regulatory approval support

Japan has a unique system for regulatory approval, which is fundamentally similar but not the same with overseas countries such as the United States and Europe. We have in-house regulatory experts with the experience of multiple regulatory approval acquisition in Japan, which can guide you to the right direction towards your product approval in Japan. Since we have the authorized license to manufacture and sell medical device, we can also be your DMAH in Japan.


(3)  Product Localization

When you want to enter the Japanese market with an existing/launched product in your country, localization of your product will be surely needed. Through our experience in developing our own product and also the co-development with our partners, we have a wealth of experience in UI/UX design for SaMD products. We are able to support your product development or UI/UX localization for the Japan market


(4) Cyber Security

Like overseas countries in order to launch your medical device product or service in Japan, complying to domestic cyber security guidelines is a must. We have engineers which have experience in developing software under guidelines such as JIS T 2304 / IEC 62304. We can also comply security guidelines in such as  2G3M/ IEC81001-5-1, develop products with the implementation of SBOM  / DevSecOps / SOUP / JIS T 81001-5-. Utilizing this capability, we are able to consult you to adequate cyber security correspondence for your business in Japan.


(5) Not Only SaMD

Our team members have extensive experience not only in the SaMD field, but also medical device in general. We have professionals which can support business development, regulatory matters, and tech. Please feel free to contact us if you need any support for your medical device business in Japan.