Translations for medical devices in 40 languages-clinical, regulatory docs
Our dedicated Medical Translation Unit at Paspartu has expert knowledge of the regulatory framework surrounding the various classes of medical devices, and the market entry requirements for different countries.
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 Directive 93/42/EEC, or with the active implantable devices Directive 90/385/EEC or with the in vitro devices Directive 98/79/EC, and from 2020, with the updated MDR.
The updated MDR effective from May 2020 brings about some important changes that affect 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 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.
By regulatory translation we mean 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:
Minimally Invasive Surgery
Cardiac rhythm management devices
Single-use Instruments/ reusable instruments
Hospital and Healthcare Products
Translations for medical devices- Types of medical documents translated:
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 (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 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
firstname.lastname@example.org or email@example.com