SunFlare is a Japanese company that provides global regulatory consulting services for medical devices.
We provide Japanese companies with comprehensive support for regulatory affairs in Japan by providing consulting services related to the following: satisfying the requirements for acquiring CE marking (e.g., transitioning to the Medical Devices Regulation [MDR], drafting a clinical evaluation report [CER] in compliance with MEDDEV 2.7/1 rev. 4, creating a system for post-marketing surveillance [PMS], and selecting a European Authorized Representative) and complying with regulatory affairs in Japan (e.g., submitting product approval applications, establishing a quality management system [QMS], and planning regulatory affairs strategies).
Founded in 1971, SunFlare is a Japanese company with over 40 years of service. We have offices in Japan (Tokyo and Osaka), France (Paris), and China (Dalian). Our diverse team has worked on a number of medical device regulatory projects for markets in Europe, Japan, and various other countries. We pledge to do our utmost to meet the regulatory needs of medical device companies. Key projects (over the past 6 years)
- CE marking acquisition: 146
- Drafting clinical evaluation reports (MEDDEV 2.7/1 rev. 4): 52
- Japanese regulatory affairs: 139