Medical Equipment & Devices

Familiarity with the regulatory framework for medical devices is an important asset of our specialised Medical Devices translation department. Medical devices are not subject to the centralised procedure, as pharmaceuticals are via EMA (European Medicines Agency). Medical devices are subject to a national approval procedure that differs from country to country. However, any medical device placed on the European market must comply with the relevant legislation, notably with Directive 93/42/EEC, or with the active implantable devices Directive 90/385/EEC or with the in vitro devices Directive 98/79/EC.

Market registration in the USA is subject to approval by FDA, just like drug products.

The European Commission has issued a guidance document for the translation of documents defining the manufacturing process - the MEDDEV guidance document referring to the translation of Labelling, Instructions for Use and Product Claims. Verified translation procedures should be in place for the accurate translation of such documents, as the safety and performance of the device may be compromised through inadequate translation, with serious consequences for the human or animal safety and health.

Paspartu has build considerable and measurable expertise in the medical regulatory translation field. Regulatory translation is the translation of documentation pertaining to the approval and compliance of medical devices, pharmaceuticals and in vitro diagnostics products. Regulatory translation requires specific knowledge of the document templates required for different countries' dossier formats.

Our translation projects have targeted the following medical branches:

  • Software & Hardware of Medical devices & equipment
  • Radiology/Ultrasound imaging
  • Diagnostics
  • Cardiology
  • Orthopedics
  • Radiology/Ultrasound imaging
  • Patient monitoring
  • Ventilation
  • Vascular
  • Sterilization/infection control
  • Cardiac rhythm management devices
  • Surgical instruments
  • Anesthesia, Catheters,
  • Neurology, Dentistry, Catheters, Endoscopy

Types of documents translated:

  • Operating, Maintenance, and Installation Manuals
  • Instructions for Use and User guides
  • Clinical trials literature
  • Regulatory Compliance Documents for European Union
  • Software Application Interfaces and Documentation
  • Package Inserts and Labels
  • Patents for Medical and Surgical Devices
  • Manufacturing Process Descriptions
  • Leaflets and brochures
  • Quality Assurance tools (QA Distiller, ErrorSpy) to check consistent use of specific terms, numbers/ values, completeness)

Our translators are native speaking professionals in the requisite language, while our revisers are Subject Matter Experts, ranging from medical technicians to clinicians and regulatory affairs experts.

Additionally, over the years Paspartu has built a rich infrastructure consisting of tools and translation knowledge database to ensure that knowledge and expertise gained from past projects is incorporated into the new ones. Indicatively these tools include:

  • Dictionaries, reference materials
  • Text analysis tools (such as WordSmith etc)
  • Tools for glossary building and maintenance
  • Translation memory tools such as Trados (effective for texts with segments that were translated earlier)
  • Quality Assurance tools (our internally devised platform Quality Cross Check, Trados QA Tools, Aspic Xbench) to check consistent use of specific terms, numbers/ values, completeness, spelling/ grammar errors, formatting, layout etc

When choosing a translation company you should make sure that your vendor is aware of certain issues that need to be taken into account when involved in translating medical devices projects:

  • Translation Skills: Successful translators in this field must have excellent translating skills, experience and an in-depth knowledge of medical terms in the specific sub-branch
  • Regulatory and Translation Criteria: accompanied documentation must meet strict language and translation criteria enforced by regulatory governmental bodies.
  • Abbreviations and acronyms: Handling abbreviations and acronyms in medical translation is extremely difficult and they need to be carefully scrutinized and proofread by medical language experts.
  • Cultural customization is key: For medical devices, accurate localization is not just about translation. When done properly, it involves cultural customization, which requires an understanding of the culture, customs, local laws and regulations of the target country.

 For any translation requests in the medical/ pharma field, please do not hesitate to contact our dedicated Life Sciences department at 

diana@paspartu.gr or info@paspartu.gr.

 

Ask for our White Paper which entails full analysis on Handling Medical Devices Translation Issues

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