SunFlare provides global regulatory consulting services for medical devices, mainly in Japanese regulatory affairs (e.g., submitting product approval applications, establishing Quality Management System (QMS)) and giving support regarding CE marking (e.g., clinical evaluation reports, MDR transition, selecting European Authorized Representatives).
SunFlare is a Japanese company with over 40 years of service since its founding in 1971. We have office locations in Tokyo and Osaka, Japan, in Paris, France, and in Dalian, China.
Our diverse team has worked on medical device regulatory projects for markets in Europe, Japan, and other countries. In the past five years, we have assisted our clients with more than 100 projects for complying with Japanese regulations, 90 projects for obtaining EU CE marking, and 30 products for preparing clinical evaluation reports in compliance with MEDDEV 2.7/1 rev.4. With this expertise, we pledge our maximum assistance in meeting the regulatory needs of medical device companies.