ISO Certified Medical Translations
Our ISO certified medical translations of clinical studies, IFUs, SOPs, manuals, Declarations of Conformity, labelling, medical software and scientific marketing literature represent a vital step in the regulatory approval and market entrance requirements for medical devices and technology.
All our medical translation processes and quality checks at Paspartu comply with the requirements of ISO17000, which is a guarantee of high standards applied for all languages and projects alike.
Medical Translation Unit
Our dedicated team is powered by native medical translators and Subject Matter Experts translating in 40 European and Asian langauges for leading medical device manufacturers worldwide.
We have expert knowledge of the regulatory framework surrounding the various classes of medical devices, technology and pharma products, and the market entry requirements for different countries.
We cover the entire Life Sciences document life cycle, with complete translation and localization solutions.
Our translation process consists of translation, review and quality control. Paspartu’s medical translation team employs various methods of quality control:
- back translation
- harmonization of 2 translated verions made by 2 different translators At the end of the translation process, we offer a free of charge Certificate of Translation Accuracy. This will attest to the accuracy and completeness of the translation and can be used with your auditors or regulatory bodies.
Why chose our medical translation solutions?
Paspartu places a great emphasis on:
- translation accuracy
- precision of terminology
- quality control
- using only native medical translators
- confidentiality and security of information
- timely delivery
- implementing client feedback
- handling document updates and versions in the target languages
- formatting in the translated languages
- creating glossaries with key terminology
Our clients in medical translation
– various regulatory bodies: The European Medicines Agency, The European Chemicals Agency
– private medical device producers, digital healthcare manufacturers, dental producers, healthacare companies, clinics, hospitals, medical software (LIMS) developers, Contract Research Organizations, biotechnoogy and pharmaceutical companies
Translations for Medical Devices & Technology- impact of MDR
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 is intended to place a greater emphasis on safety, with more requirements for clinical evidence and increased oversight by regulatory agencies.
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
- localization of medical software and its updated versions
- translations required in more languages
- using an approved, certified and audited translation vendor ranked as critical supplier
Subfields of medical expertise covered by Paspartu:
- Diagnostics
- In-vitro Diagnostics- IVD
- Laboratory
- Endoscopy
- Urology
- Gynaecology
- Radiology
- Orthopaedics
- Minimally invasive surgery
- Cardiology
- Respiratory medicine
- Reproductive medicine, fertifility, embriology
- Sterilization
- Body monitoring systems- connected healthcare
- Fertility medicine
- Laser equipment
- Optics
- Medical software
- Dentistry
Curiour to check some of our recent medical translation projects https://www.paspartutranslations.com/life-science-medical-and-pharma-translation/
Feel free to ask for a free translation sample/ quotation here- diana@paspartu.gr