Medical Device

Translation Services

Documentation for medical devices can pose a unique challenge since it requires both technical and medical expertise to translate.

We prioritise compliance, accuracy and readability in all our translated materials.

Established in 1962, DWL has the knowledge and experience to handle all technical, patient-facing and promotional documents, and to produce translations that are clear, accurate and fit for purpose.

Safe and compliant use of medical devices is essential to ensure positive health outcomes and commercial success.

DWL accurately translates and updates all documents required to commercialise and maintain your medical device on each target market, including:

  • Summaries of Safety and Clinical Performance (SSCP)
  • Instructions for use (IFUs) and packaging
    Operator’s/Instruction manuals
  • Surgical brochures
  • Patient leaflets
  • Package inserts and labelling
  • Websites
  • Promotional materials
  • Product Information for drug/device combination products
  • Field safety notices
  • Data sheets
  • Technical specifications

 

DWL adds value during the process of regulatory approval of medical devices:

Clarity

Identify what needs translation under MDR 2017/745, such as the newly required Summary of Safety and Clinical Performance (SSCP).​

Readability

Precise language tailored to the user, caregiver or physician.

Technology

Documents are translated and returned in the right format.

Strategy

Support with planning medical device registrations in cooperation with established European regulatory consultants.

Quality

In-house medical expertise underpinned by experienced freelance linguists within an ISO 9001-certified Quality Management System.

Medical Device companies rely on us to provide a quality translation service.

This includes the EU Regulation on Medical Devices 2017/745, EU Regulation on In Vitro Diagnostic Medical Devices 2017/746 and United Kingdom Conformity Assessment (UKCA).

Featured Capabilities

eLearning

Dedicated Translation and Localization Solutions to Make eLearning Global

Translation

Connect Your Brand to a Global Audience With Our Fully Customizable Services

Transcreation

Expand Your Messaging and Voice Into New Cultures, Regions, and Ways of Thinking

The World's Most Secure Translation Environment™

Security is Our Top Priority

We cannot stress enough the importance of information security. It’s extremely risky to engage with vendors who can’t demonstrate at an organizational level how they keep your content secure from Intellectual Property theft and information leaks. 

We are the only language services provider that holds an independently audited SOC 2 Type 2 report on an organizational level — which goes far beyond just having super secure platforms. Our entire organization has your back to protect your information, your currency, with LanguageVault.

Speak to us today about your Medical Device Translation Needs!

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