SunFlare Co., Ltd. of Tokyo at MEDICA 2019 in Düsseldorf -- MEDICA - World Forum for Medicine
Manage stand orders
Select Option
Manufacturers Service

SunFlare Co., Ltd.

Shinjuku Hirose Bldg., 4-7 Yotsuya, Shinjuku-ku, 160-0004 Tokyo
Japan
Telephone +81 3 3355 1383
Fax +81 3 3355 0270
info@sunflare.co.jp

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

Hall map

MEDICA 2019 hall map (Hall 15): stand K10

Fairground map

MEDICA 2019 fairground map: Hall 15

Contact

Narumi Ebata

Associate Consultant
Research & Consulting Division

Tokyo, Japan

Phone
+81 3 3355 1383

Email
info@sunflare.co.jp

Visit us

Hall 15 / K10

18.11.2019

Topic

all-day

Meetings with potential business partners

SunFlare is a Japanese company that provides global regulatory consulting services for medical devices.

At our booth, we will be presenting information on the consulting services (see below) that we provide with respect to medical device regulatory affairs in Europe and Japan. We also hope to hold discussions with prospective partner companies (e.g., European Authorized Representatives and product testing bodies) that are interested in working with us in providing support for Japanese manufacturers and other companies that aim to export products to Europe.

Our booth will be located at K10 in Hall 15. We look forward to seeing you there!

Key services
Consulting services related to the following:
acquiring CE marking, complying with various medical device standards, complying with regulatory affairs, acquiring ISO 13485 certification, and entering the medical device market
* See “Our products” for details.

More Less

19.11.2019

Topic

all-day

Meetings with potential business partners

SunFlare is a Japanese company that provides global regulatory consulting services for medical devices.

At our booth, we will be presenting information on the consulting services (see below) that we provide with respect to medical device regulatory affairs in Europe and Japan. We also hope to hold discussions with prospective partner companies (e.g., European Authorized Representatives and product testing bodies) that are interested in working with us in providing support for Japanese manufacturers and other companies that aim to export products to Europe.

Our booth will be located at K10 in Hall 15. We look forward to seeing you there!

Key services
Consulting services related to the following:
acquiring CE marking, complying with various medical device standards, complying with regulatory affairs, acquiring ISO 13485 certification, and entering the medical device market
* See “Our products” for details.

More Less

20.11.2019

Topic

all-day

Meetings with potential business partners

SunFlare is a Japanese company that provides global regulatory consulting services for medical devices.

At our booth, we will be presenting information on the consulting services (see below) that we provide with respect to medical device regulatory affairs in Europe and Japan. We also hope to hold discussions with prospective partner companies (e.g., European Authorized Representatives and product testing bodies) that are interested in working with us in providing support for Japanese manufacturers and other companies that aim to export products to Europe.

Our booth will be located at K10 in Hall 15. We look forward to seeing you there!

Key services
Consulting services related to the following:
acquiring CE marking, complying with various medical device standards, complying with regulatory affairs, acquiring ISO 13485 certification, and entering the medical device market
* See “Our products” for details.

More Less

21.11.2019

Topic

all-day

Meetings with potential business partners

SunFlare is a Japanese company that provides global regulatory consulting services for medical devices.

At our booth, we will be presenting information on the consulting services (see below) that we provide with respect to medical device regulatory affairs in Europe and Japan. We also hope to hold discussions with prospective partner companies (e.g., European Authorized Representatives and product testing bodies) that are interested in working with us in providing support for Japanese manufacturers and other companies that aim to export products to Europe.

Our booth will be located at K10 in Hall 15. We look forward to seeing you there!

Key services
Consulting services related to the following:
acquiring CE marking, complying with various medical device standards, complying with regulatory affairs, acquiring ISO 13485 certification, and entering the medical device market
* See “Our products” for details.

More Less

Our products

Product category: Reports and analyses

Global Regulatory Consulting Services for Medical Devices

SunFlare is a Japanese company that provides global regulatory consulting services for medical devices.

Our key consulting services are related to the following: satisfying the requirements for acquiring CE marking (e.g., transitioning to the Medical Devices Regulation [MDR], creating a new clinical evaluation plan in compliance with MEDDEV 2.7/1 rev. 4, creating a system for post-marketing surveillance [PMS], and selecting a European Authorized Representative) and complying with regulatory affairs in Japan (e.g., submitting product approval applications, establishing a quality management system [QMS], and planning regulatory affairs strategies).

More Less

Product category: Reports and analyses

Consulting services for acquiring CE marking

  • Assisting in the transition to the Medical Device Regulation (MDR)
  • Drafting clinical evaluation reports (MEDDEV 2.7/1 rev. 4)
  • Drafting technical files (STED)
  • Establishing a vigilance system
  • Establishing a post-market surveillance (PMS) system
  • Selecting a European Authorized Representative
  • Selecting a product testing body

More Less

Product category: Reports and analyses

Consulting services for compliance with standards during design development

  • IEC 60601-1 Edition 3.1 (Medical electrical equipment)
  • IEC 60601-1-2 (Electromagnetic compatibility)
  • IEC 62366-1 (Usability engineering)
  • IEC 62304 (Medical device software — Software life cycle processes)
  • ISO 10993-1 (Biological evaluation of medical devices)
  • ISO 14971 (Medical devices — Application of risk management to medical devices)
  • Gap analysis of market-specific regulatory requirements

More Less

Product category: Reports and analyses

Consulting services for acquiring ISO 13485 certification

  • Gap analysis
  • Establishing a quality management system (QMS)
  • Preparing QMS-related documents

More Less

Product category: Reports and analyses

Consulting services for regulatory affairs in Japan

  • Formulating and planning regulatory strategies
  • Establishing a QMS
  • Applying for product approval
  • Post-marketing regulatory affairs
  • Applying for coverage under Japan’s National Health Insurance (NHI) system

More Less

Product category: Reports and analyses

Consulting services for entering the medical device market in Japan

  • Establishing QMS and GVP systems
  • Acquiring a license, submitting a registration application, and submitting a business notification
  • Applying for product approval/notification

More Less

Company news

Date

Topic

Download

Sep 11, 2019

Hosted an exhibition booth at MEDICAL FAIR THAILAND 2019

More Less

Nov 12, 2018

Hosted an exhibition booth at MEDICA 2018

More Less

Nov 13, 2017

Hosted an exhibition booth at MEDICA 2017

More Less

About us

Company details

SunFlare is a Japanese company that provides global regulatory consulting services for medical devices.

We provide Japanese companies with comprehensive support for regulatory affairs in Japan by providing consulting services related to the following: satisfying the requirements for acquiring CE marking (e.g., transitioning to the Medical Devices Regulation [MDR], drafting a clinical evaluation report [CER] in compliance with MEDDEV 2.7/1 rev. 4, creating a system for post-marketing surveillance [PMS], and selecting a European Authorized Representative) and complying with regulatory affairs in Japan (e.g., submitting product approval applications, establishing a quality management system [QMS], and planning regulatory affairs strategies).

Founded in 1971, SunFlare is a Japanese company with over 40 years of service. We have offices in Japan (Tokyo and Osaka), France (Paris), and China (Dalian). Our diverse team has worked on a number of medical device regulatory projects for markets in Europe, Japan, and various other countries. We pledge to do our utmost to meet the regulatory needs of medical device companies.

Key projects (over the past 6 years)
  • CE marking acquisition: 146
  • Drafting clinical evaluation reports (MEDDEV 2.7/1 rev. 4): 52
  • Japanese regulatory affairs: 139

More Less

Company data

Sales volume

10-49 Mio US $

Number of employees

100-499

Foundation

1971

Area of business

Medical Services and Publications