SunFlare Co., Ltd. of Tokyo at MEDICA 2018 in Düsseldorf -- MEDICA - World Forum for Medicine

SunFlare Co., Ltd.

Shinjuku Hirose Bldg., 4-7, Yotsuya, Shinjuku-ku, 160-0004 Tokyo
Japan
Telephone +81 3 33551383
Fax +81 3 33550270
info@sunflare.co.jp

This company is co-exhibitor of
Foundation for Biomedical Research and Innovation

Hall map

MEDICA 2018 hall map (Hall 16): stand B51

Fairground map

MEDICA 2018 fairground map: Hall 16

Contact

Shinya Arikawa

Consultant
Research and Consulting Division

Tokyo, Japan

Phone
+81-3-3355-1383

Email
info@sunflare.co.jp

Visit us

Hall 16 / B51

12.11.2018

Topic

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all-day

Global regulatory consulting services for medical devices

Please visit our booth to learn more about our consulting services on medical device regulatory affairs in Europe and Japan.
We are happy to discuss what we can do for your company.

SunFlare provides global regulatory consulting services for medical devices, mainly in Japanese regulatory affairs (e.g., submitting product approval applications, establishing Quality Management System (QMS)) and giving support regarding CE marking (e.g., clinical evaluation reports, MDR transition, selecting European Authorized Representatives).

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13.11.2018

Topic

Download

all-day

Global regulatory consulting services for medical devices

Please visit our booth to learn more about our consulting services on medical device regulatory affairs in Europe and Japan.
We are happy to discuss what we can do for your company.

SunFlare provides global regulatory consulting services for medical devices, mainly in Japanese regulatory affairs (e.g., submitting product approval applications, establishing Quality Management System (QMS)) and giving support regarding CE marking (e.g., clinical evaluation reports, MDR transition, selecting European Authorized Representatives).

More Less

14.11.2018

Topic

Download

all-day

Global regulatory consulting services for medical devices

Please visit our booth to learn more about our consulting services on medical device regulatory affairs in Europe and Japan.
We are happy to discuss what we can do for your company.

SunFlare provides global regulatory consulting services for medical devices, mainly in Japanese regulatory affairs (e.g., submitting product approval applications, establishing Quality Management System (QMS)) and giving support regarding CE marking (e.g., clinical evaluation reports, MDR transition, selecting European Authorized Representatives).

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15.11.2018

Topic

Download

all-day

Global regulatory consulting services for medical devices

Please visit our booth to learn more about our consulting services on medical device regulatory affairs in Europe and Japan.
We are happy to discuss what we can do for your company.

SunFlare provides global regulatory consulting services for medical devices, mainly in Japanese regulatory affairs (e.g., submitting product approval applications, establishing Quality Management System (QMS)) and giving support regarding CE marking (e.g., clinical evaluation reports, MDR transition, selecting European Authorized Representatives).

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Our range of products

Product categories

  • 07  Medical Services and Publications
  • 07.01  Reports and analyses

Our products

Product category: Reports and analyses

Global regulatory consulting services for medical devices

SunFlare provides global regulatory consulting services for medical devices, mainly in Japanese regulatory affairs (e.g., submitting product approval applications, establishing Quality Management System (QMS)) and giving support regarding CE marking (e.g., clinical evaluation reports, MDR transition, selecting European Authorized Representatives).

Regulatory assistance services in Japan
  • Formulating and planning regulatory strategies
  • Quality Management System (QMS)
  • Applying for product approval
  • Post-marketing regulatory affairs
  • Applying for coverage under Japan’s National Health Insurance (NHI) system

European CE marking assistance
  • MDD(Medical Device Directive)
  • MDR(Medical Device Regulation)
  • Clinical Evaluation  (MEDDEV 2.7/1 rev.4)
  • Drafting of technical files and design dossiers
  • Post-marketing safety management
  • Selecting a European Authorized Representative

Assistance for entering the medical device market
  • QMS and GVP systems
  • Acquiring a license, submitting a registration application, and submitting a business notification
  • Applying for product approval/notification

Assistance with standards compliance during the design and development process
  • IEC 60601-1, ed. 3.1 Medical electrical equipment
  • ISO 14971 Risk management
  • IEC 62366 Usability Engineering
  • IEC 62304 Software Life Cycle Processes 
  • Gap analysis of market-specific regulatory requirements

Consulting services for acquiring ISO 13485 certification
  • Gap analysis
  • Establishing a QMS
  • Preparing QMS-related documents

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Company news

Date

Topic

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Oct 1, 2018

Key projects from the past 5 years

  • Assistance services related to regulatory affairs in Japan: 100 projects
  • Assistance services related to European CE marking: 90 projects
  • Assisting in the preparation of clinical evaluation reports(MEDDEV 2.7/1 rev.4) : 30 projects

SunFlare provides global regulatory consulting services for medical devices, mainly in Japanese regulatory affairs (e.g., submitting product approval applications, establishing Quality Management System (QMS)) and giving support regarding CE marking (e.g., clinical evaluation reports, MDR transition, selecting European Authorized Representatives).

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About us

Company details

SunFlare provides global regulatory consulting services for medical devices, mainly in Japanese regulatory affairs (e.g., submitting product approval applications, establishing Quality Management System (QMS)) and giving support regarding CE marking (e.g., clinical evaluation reports, MDR transition, selecting European Authorized Representatives).

SunFlare is a Japanese company with over 40 years of service since its founding in 1971. We have office locations in Tokyo and Osaka, Japan, in Paris, France, and in Dalian, China.

Our diverse team has worked on medical device regulatory projects for markets in Europe, Japan, and other countries. In the past five years, we have assisted our clients with more than 100 projects for complying with Japanese regulations, 90 projects for obtaining EU CE marking, and 30 products for preparing clinical evaluation reports in compliance with MEDDEV 2.7/1 rev.4. With this expertise, we pledge our maximum assistance in meeting the regulatory needs of medical device companies.

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Company data

Sales volume

10-49 Mio US $

Number of employees

100-499

Foundation

1971

Area of business

Medical Services and Publications