- Assistance services related to regulatory affairs in Japan: 100 projects
- Assistance services related to European CE marking: 90 projects
- Assisting in the preparation of clinical evaluation reports(MEDDEV 2.7/1 rev.4) : 30 projects
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).
Exhibitor Data Sheet