Medical Devices

The medical devices industry is undergoing rapid growth and change with emerging markets driving the largest increase in demand. However, huge linguistic and cultural barriers exist between different regions; in order to increase awareness among patients and physicians in these markets, manufacturers increasingly need to customise their product marketing approach to suit local audiences.

We provide an end-to-end service, from patent translations to marketing support for product launches, to increase the likelihood of success when releasing a medical device in a new territory.

TOPPAN Digital Language employs only trained medical practitioners to work on medical device translations, and all of our staff and linguists have signed confidentiality agreements. We can also sign specific non-disclosure agreements of your own if necessary. We also understand the high risk nature of medical device translations, and are prepared to handle such delicate content with care, precision, and a high level of professionalism.

We can help you with:

  • Patents for medical devices
  • Package labels and inserts
  • Operating, maintenance, installation and instruction manuals
  • Development Safety Update Reports (DSURs)
  • Regulatory compliance documents
  • Software user interfaces and documentation
  • Suspected unexpected serious adverse reactions (SUSARs)
  • And more

Our services

LingVal (Linguistic Validation) & eCOAProduct development and launch

  • Forward & back translation
  • Reconciliation
  • Harmonisation
  • Screenshot review
  • Digitization migration
  • Updates post-CogDev
  • Patient mobile app localization

ClinicalPatient recruitment and clinical protocols

  • ICFs (Informed Consent Forms)
  • Clinical protocols & synopsis
  • Investigator brochures
  • RA (Regulatory Authority) / EC (Ethics Committee) correspondence
  • Clinical Trial Agreements
  • Clinical Study Report
  • Patient recruitment material
  • Patient diaries and booklets
  • Adjudication
  • COA/ eCOA (electronic Clinical Outcome Assessment)

Medical DevicesPrecise end-to-end translations

  • Patents for medical devices
  • Package labels and inserts
  • Operating, maintenance, installation and instruction manuals
  • Development Safety Update Reports (DSURs)
  • Regulatory compliance documents
  • Software user interfaces and documentation
  • Suspected unexpected serious adverse reactions (SUSARs)


LegalSafety and pharmacovigilance

  • AEs (Adverse Events) / SAEs (Serious Adverse Event)
  • Product recalls
  • Good Practices (GxP)
  • Safety specialist

MarketingBrand management and localisation

  • Press releases
  • Newsletters
  • Websites
  • Investor relations
  • Code of conducts
  • Legal translations (M&A; eDiscovery; litigation; contracts)

Learning & DevelopmentLearning modules, interpretation, and internal compliance

  • Educational material
  • Sales training modules
  • Compliance modules
  • eLearning localization


Why our clients choose us: the 3Ts of TOPPAN.

Talent

Talent

  • We strive to attract and develop the best talent in the industry for first-class service to our customers
  • We are intentional in creating a respectful, diverse, and ambitious team
  • We hand-pick native-speaking expert linguists and always pay them fairly
Technology

Technology

  • We build our tech with trusted expert advice for your industry content needs
  • Our proprietary tech platform, Stream, is easy to use and easy to implement
  • We continuously innovate with the most appropriate tech through a long-term approach
Tailored to you

Tailored to you

  • We partner with your team through consultative engagement
  • We focus on addressing your specific pain points with bespoke solutions
  • We deliver first-class service with operational excellence – quality, security, and on-time delivery
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