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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