A TESTED, MDR COMPLIANT MEDICAL TRANSLATION PROCESS
for your IFUs & 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.
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.
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.
This is how the updated MDR affects your document translation strategy:
– need to update IFUs to be more detailed, and subsequently translate the updated versions
– in more languages
– using an approved, certified and audited translation vendor
Our tested, MDR compliant translation process involves translation of native medical translators, review by a a different Subject Matter Expert, and Quality Control. A Certificate of Translation Accuracy is issued 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!
Send your translation query or file for a free translation quote at firstname.lastname@example.org/ email@example.com!