An MDR COMPLIANT MEDICAL TRANSLATION PROCESS
for your IFUs, manuals & labeling in 40 languages
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.
For the past 16 years we have worked closely to regulatory and marketing teams in leading medical technology producers worldwide, to improve medical translation processes and costs in 40 languages.
17100 ISO certified medical translation agency
Paspartu places a great emphasis on ISO certified and controlled processes:
- translation accuracy
- using only native medical translators
- confidentiality and security of information
- timely delivery
- implementing client feedback
Medical devices are subject to national approval prpcedures
In Europe, medical devices are not subject to the centralised procedure, but to a national approval procedure that differs from country to country.
The updated MDR regulations are intended to place a greater emphasis on safety, with greater requirements for clinical evidence and increased oversight by regulatory agencies.
Moreover, the MDR covers devices that previously fell under two separate European directives, the Medical Devices Directive (MDD) and the Active Implantable Medical Devices Directive (AIMDD); in vitro diagnostic devices will be covered by the new In Vitro Diagnostics Directive.
MDR impact on multilingual translation for medical devices
- need to update IFUs to be more detailed, and subsequently translate the updated versions
- localization of medical software and its updated versions
- translations required in more languages
- using an approved, certified and audited translation vendor
Our tested, MDR compliant translation process involves:
- translation by native medical translators
- review by a a different Subject Matter Expert
- strict Quality Control procedures for all documents and languages alike
Last but not least, Paspartu will issue a Certificate of Translation Accuracy at the end of the translation process, free of charge. This will attest to the accuracy and completeness of the translation and can be used with your regulatory body.
Indeed, the MDR updates may sound tricky and are still causing a lot of confusion amongst medical device producers- luckily, Paspartu is here to help! The article below can show you how!
Check here how we manage complex, real translation projects for key medical technology manufacturers!
Get in touch with our dedicated Medical Translation Team – firstname.lastname@example.org for a free quotation/ translation sample!