SunFlare Co., Ltd.

Total support for medical device regulatory affairs

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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
      • Research
        Investigation of laws, regulations, standards and products
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"Usability engineering" Seminars

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  • ISO 14971
  • Usability engineering
  • IEC 62304
  • FDA
  • Regulatory affairs in Japan
  • AMDD
  • ISO 13485
  • CE marking
  • Europe

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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
    • 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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