Medical Products Supplies Companies

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
https://md.sunflare.com/en/

Product Categories

Product categories

07 Medical Services and Publications
07.01 Reports and analyses

Reports and analyses

Global Regulatory Consulting Services for Medical Devices
Consulting services for acquiring CE marking
Consulting services for compliance with standards during design development
Consulting services for acquiring ISO 13485 certification
Consulting services for regulatory affairs in Japan
Consulting services for entering the medical device market in Japan

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).

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

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

Product category: Reports and analyses
Consulting services for acquiring ISO 13485 certification

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

Consulting services for acquiring ISO 13485 certification/SunFlare Co., Ltd.

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

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

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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

Company data
Sales volume

10-49 Mio US $
Number of employees

100-499
Foundation

1971
Area of business

Medical Services and Publications

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