SunFlare Co., Ltd.

Total support for medical device regulatory affairs

  • English
  • Japanese
    • Services
      About service
      • 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]

Consulting services for Japanese and overseas regulatory affairs

  1. Home
  2.  
  3. Services
  4.  
  5. Consulting services for Japanese and overseas regulatory affairs

Regulatory affairs in Japan

Strategies for regulatory affairs
QMS establishment, operation and maintenance
Design development and technical documents
Product approval applications
Post-marketing regulatory affairs
National Health Insurance (NHI) coverage
Fixed-term contracts

See details

Acquisition of CE marking

CE marking requirements
Transition to the Medical Devices Regulation (MDR)
Clinical evaluations
Technical files and design dossiers
EN ISO 13485-compliant QMS
Consulting services related to selecting a European Authorized Representative
Post-marketing safety management activities
Benefits of CE marking in ASEAN countries
Medical Device Regulation (MDR)

See details

Entry into the medical device market

Overview of entry into the medical device market
QMS and GVP systems
Business licensing, registration and notification
Product approval/notification applications

See details

Compliance with standards during design development

Design development and technical documents
Key medical device standards
Japanese and overseas requirements

See details

Acquisition of ISO 13485 certification

ISO 13485 requirements
Strategic decisions
Client compliance with requirements
QMS development and documents
QMS operation

See details

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.

Contact form

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

Page Top

  • Privacy Policy

© 2023 SunFlare Co., Ltd. All Rights Reserved.