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Medical Devices

Solution Case Studies

Helping you to expand your business globally — whatever the language, whatever the country

Expanding your business globally involves two stages: (1) an input stage, in which you collect information and conduct research on the target countries; and (2) an output stage, in which you create the documentation you need. Language can be a major obstacle in both of these stages, but SunFlare s expert services provide the support you need to overcome this.

Research and information gathering in almost any language

  • Research on national laws and regulations
  • Research on trends in sterilization-related regulations in France
  • Detailed research on the medical device license system employed in South Korea
  • Detailed research on the medical device re-registration system employed in China
  • Summary research on the medical device regulations that exist in Indonesia, the Philippines, Saudi Arabia, and other developing countries
  • Reference translations of international standards that have yet to be officially translated
  • Japanese translation of IEC 60601-2-XX prior to the publication of its official translation, etc.
  • Research and information gathering on non-conformance
  • Information gathering on similar instances of non-conformance through the periodic monitoring of France’s AFSSAPS website
  • Preparation of technical documents from overseas manufacturers
  • Extraction from FDA submissions of Summary Technical Documents (STED) and appendix documents, followed by preparation and translation of the relevant parts
  • Research, collating, and summarizing of prior art literature
  • Research on Chinese patent clearance
 Customer workflow

Preparation of highly specialized documents

  • Third-party checks on development/design documents
  • Logic checks by third parties on risk analysis documents
  • Logic checks by native English speaking professionals on English audit documents
  • Support for the preparation of regulatory dossiers to be submitted in Japan
  • Preparation of applications to be submitted in Japan, based on overseas submissions for the products of non-Japanese manufacturers
  • Support for the preparation of regulatory dossiers to be submitted overseas, and the carrying out of third-party checks on such documents
  • Preparation of submissions for China’s CFDA registration system, based on Japanese submissions
  • Content checks for submissions documents by back translation from the local language into Japanese
  • Support for the preparation of multi-language versions of product manuals
  • Risk analysis and consistency checks for product manuals
  • Creation of multi-language databases for cautions and warnings
  • Support for the preparation of advertisements and commercial messages that comply with the regulations of the relevant country
  • Preparation of draft papers on clinical results
  • Preparation of marketing or training materials for local subsidiaries and sales agents based overseas
  • Support for the preparation of reports on product defects
  • Support for speedy communication with corporations, agencies, and manufacturers based overseas