SunFlare Co., Ltd.

Total support for medical device regulatory affairs

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    • Services
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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
      • Research
        Investigation of laws, regulations, standards and products
      • Seminar,Event
        Event planning
      • Translation
        Translation services for medical device documents
    • Project workflow
    • Event calendar
    • Contact
    • [Japanese]

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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

  • Contact

Translation services for medical device documents

  • Contact

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
    • 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
  • Event calendar
  • 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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