Total support for medical devices regulatory affairs/SunFlare
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Consulting services related to Japanese and overseas regulatory affairs
Regulatory assistance services in Japan
European CE marking assistance
Assistance for entering the medical device market
Assistance with standards compliance during the design and development process
Consulting services for acquiring ISO 13485 certification
Investigations related to laws and regulations, standards and products
Seminars and events
Translation services for medical device documents
Workflow up to project kickoff
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Services
Consulting services for Japanese and overseas regulatory affairs
Regulatory affairs in Japan
Acquisition of CE marking
Entry into the medical device market
Compliance with standards during design development
Acquisition of ISO 13485 certification
Investigation of laws, regulations, standards and products
Investigation related to laws and regulations, standards and products
Investigation of differences in regulatory and standard requirements
Roadmap investigation for marketing a medical device
Event planning
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Translation services for medical device documents
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