Medical Devices

Medical Device Translation Service

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

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.

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

RELY ON US.

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

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.

DWL will help you launch your product to market and keep all documentation compliant with regulatory requirements.

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), both of which come into force this year.

For guidance on the linguistic aspects of either of these regulations, don’t hesitate to get in touch.