Translation for medical devices in 40 languages- clinical, regulatory, marketing documentation.
Our dedicated Medical Translation Unit at Paspartu has expert knowledge of the regulatory framework surrounding the various classes of medical devices and technology, and the market entry requirements for different countries.
Our main markets are: Germany, Switzerland, Austria, Italy, Spain, Portugal, Belgium, Netherlands, Sweden, Denmark, Poland, Greece, UK< Ireland, Canada, USA.
In Europe, medical devices are not subject to the centralised procedure, as pharmaceutical products are via the EMA (European Medicines Agency). Medical devices are subject to a national approval procedure that differs from country to country. Therefore, any medical device placed on the European market must comply with the relevant legislation, notably with (EU) 2017/745 (MDR), and for IN Vitro medical devices the (EU) 2017/746 (IVDR) . The updates MDR regulations are applicable from May 2021, and respectively May 2022 for the IVDR regulation.
These regulations bring about some important changes that affect document translation strategy as well, with a focus on the need to translate more detailed IFUs, in more languages, and moving translation up in the workflow, from post CE marking to the technical dossier phase (for IFUs & labeling).
Market registration in the USA is subject to approval by FDA, just like drug products.
The European Commission has issued a guidance document covering the translation for medical devices documentation – 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 translation field, for regulatory documentation.
By regulatory translation we mean translation of documentation pertaining to the approval and compliance of medical devices, and in vitro diagnostics products. Regulatory translation requires specific knowledge of the document templates required for different countries’ dossier formats.
Our translation projects focus on the following medical branches:
Radiology/Ultrasound imaging
Diagnostics/ IVD
Cardiology
Orthopedics
Radiology/Ultrasound imaging
Patient monitoring
Urology
Minimally Invasive Surgery
Wound Management
Ventilation
Vascular
Sterilization/infection control
Cardiac rhythm management devices
Surgical instruments
Anesthesia
Respiratory medicine
Reproductive medicine
Catheters
Neurology
Dentistry
Endoscopy
Veterinary medicine
Single-use Instruments/ reusable instruments
Hospital and Healthcare Products
Translations for medical devices- Types of medical documents translated:
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Our translators are native speaking professionals in the target language, while our revisers are Subject Matter Experts, ranging from medical technicians to physicians, 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.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 or Memsource (showing text segments that have been previously translated, in order to save time and improve consistency of terminology)
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 medical translation company you should consider a few factors:
Translation Skills: Successful translators in the medical field must have excellent translating skills, experience and an in-depth knowledge of medical terms in the specific sub-branch
Regulatory and Translation Criteria: translated 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.
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
