Specialist Fields

TEL 03-3355-1168

Medical Devices

Our outstanding language skills and professional expertise provide the optimal solution to your documentation needs

The services we provide in the medical devices field improve our customers’ business efficiency and reduce their product launch times. By leveraging our language skills and specialist experience, we provide our customers with a wide range of services that support their business development, including the conducting of research on patents, standards, and legal regulations; the creation of multi-language documentation; and the provision of support on pharmaceutical regulations.

As an active partner that supports you through all phases of your product development—from product planning through to post-marketing services—we provide solutions that are tailored to your individual needs.

Services We Offer

Services We Offer

■ Research and Development Support

  • Preparation of research papers and academic presentations
  • Authoring and English translation of papers, conducting of rule checks, editing by native English speaking professionals with PhD degrees, designing and printing of posters for academic conferences, audio transcriptions, preparation of presentation materials, voice recordings by native English speakers, paper-writing training
  • Research on prior art and literature
  • Research on prior art, support for the preparation of detailed statements for overseas submissions, third-party checks on detailed statements for overseas submissions

■ Design and Regulatory Affairs Support

  • Preparation of technical documents
  • Risk analysis and cross-checking of instruction manuals, reviews to ensure consistency between documents and standards/legal regulations, checking of mathematical equations in design calculations, test reports, risk analysis, process validation, DTP editing of machine structure diagrams and labels, checking of domestic submission materials against overseas data, reviews of design documents
  • Preparation of regulatory dossiers
  • Preparation of domestic submissions based on overseas data, collection of clinical evaluation documents and past safety information

■ Marketing and Post-Marketing Support

  • Preparation of marketing materials
  • Preparation of papers based on clinical results and improvements to exhibition presentation materials
  • Post-marketing surveillance
  • Preparation of non-conformance reports, support for the preparation of safety information reports for overseas patients, support for the English translation of non-conformance reports, development of automatic workflow systems, research on documents that have similar examples, collection of relevant documents, creation of abstracts

■ Entering Overseas Markets

  • Research on national laws, regulations, and standards
  • Research on regulations and standards in Europe, Asia and South America; monitoring of legal revisions; support for creating and disseminating public statements on revisions to standards
  • Preparation of multi-language marketing materials
  • Preparation and localization of marketing materials for different countries
  • Multi-language translations of instruction manuals
  • Localization, cross-checking of manuals against regulations and risk analysis
  • China market entry
  • Market research, consultations on sales-channel development, regulatory affairs representative service, etc.

Documents We Handle

Instruction manuals, study reports, summary technical documents, package inserts, patent specifications, pre-publication papers, non-conformance reports, risks analyses, product pamphlets, process validations, overseas ordinances, international standards, machine-structure diagrams, etc.