Professional translation services for specialist medical device documents

The medical device market is growing not just in Japan, but in other parts of the world as well. Since this market growth is expected to continue, it is essential that growth-oriented businesses take the actions necessary to launch their medical device products in overseas markets. A critical part of launching medical devices overseas is the quick and effective localization of related documents.

Backed up by exceptional linguistic capabilities and a wealth of practical experience in a wide variety of specialist fields, SunFlare can handle the translation of documents for all phases of your product’s development, from research, planning, and development of your product through to applying for its registration and conducting post-marketing.

Services available

  • Translation
  • Proofreading by a native speaker
  • Translation verification
  • Audio transcription and revision
  • Video audio translation, captioning, and dubbing
  • Printing
  • DTP (layout editing)

Document types

  • Applications and summary technical documentation (STED), package inserts, technical documents, risk management documents, enquiries from regulatory authorities or notified bodies
  • Investigator brochures, clinical study reports, protocols, malfunction reports, documents related to post-marketing surveillance
  • Quality manuals, standard operating procedures (SOPs), research papers, user manuals, audit-related documents
  • Presentation materials, website content, sales promotion materials
  • Regulations, standards, notifications, guidelines, etc.

Key fields of expertise

  • Therapeutic devices
    • Stents, catheters, guidewires, blood purifiers, dialyzers, rehabilitation assistance devices, vascular prostheses, artificial bones, defibrillators, surgery-related devices, etc.
  • Diagnostic devices
    • Diagnostic imaging systems, endoscopes, analyzers, monitors, medical device software, etc.
  • Other
    • Suture needles, dental products, surgical disposable products, culture-related products, robotic medical devices, etc.