SunFlare provides continuous, one-stop assistance for complying with the PMD Act and overseas regulations at every stage from medical device development through commercialization.
Medical device registration application, ISO 13485, European CE marking, market launch, standards compliance, etc.
Investigation of laws and regulations, investigation of differences in regulatory and standard requirements, road map investigation, etc.
Applications/STED for marketing approval, QMS-related documents, marketing materials, regulations and standards in different countries, etc.
On-site seminars, courses, human resources development programs, etc.