SunFlare Co., Ltd.

Total support for medical device regulatory affairs

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    • Services
      About service
      • Services
      • Consulting services for Japanese and overseas regulatory affairs
      • Regulatory affairs in Japan
      • Acquisition of CE marking
      • US Market Entry
      • Entry into the medical device market
      • Compliance with standards during design development
      • Acquisition of ISO 13485 certification
      • Acquisition of MDSAP Certification
      • Research
        Investigation of laws, regulations, standards and products
      • Seminar,Event
        Event planning
      • Translation
        Translation services for medical device documents
    • Project workflow
    • Contact
    • [Japanese]

Investigation of laws, regulations, standards and products

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Laws, regulations, standards and products

Overseas launch of medical devices
Overseas launch of quasi-medical devices

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Differences in regulatory and standard requirements

Differences in various technical and national standards
Differences between standards and the clients current system in preparation for obtaining certification/approval for a medical device

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Roadmaps for marketing medical devices

Roadmap investigation for the launch of a new medical device
Market investigation for the overseas launch of a medical device

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Services

Consulting services for Japanese and overseas regulatory affairs

Investigation of laws, regulations, standards and products

Translation services for medical device documents

Event planning

Contact

If you have any questions about our services, please contact us via the link below.

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Services

  • Consulting services for Japanese and overseas regulatory affairs
    • Regulatory affairs in Japan
    • Acquisition of CE marking
    • US Market Entry
    • Entry into the medical device market
    • Compliance with standards during design development
    • Acquisition of ISO 13485 certification
    • Acquisition of MDSAP Certification
  • Investigation of laws, regulations, standards and products
    • Laws, regulations, standards and products
    • Differences in regulatory and standard requirements
    • Roadmap for marketing medical devices
  • Event planning
  • Translation services for medical device documents
  • Project workflow
  • Contact
  • Company profile

SunFlare Co., Ltd.

SunFlare Co., Ltd.

Shinjuku Hirose Bldg., 4-7 Yotsuya, Shinjuku-ku, Tokyo 160-0004, Japan

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