IDO: shoulder arthroplasty translated in multiple languages
When it comes to utilizing medical devices categorized as type III, the Medical Device Regulation (MDR) mandates that all necessary steps be taken to manage risk. The regulation's intent is unmistakable: the higher the risk, the more stringent the measures required.
In light of this, IDO crafted a translation process that adheres to the MDR's guidelines. After having translated their IFUs with the help of orthopedic surgeons, they needed to verify its accuracy and ensure that linguistic excellence had not been sacrificed during the translation process. This is where they sought our assistance to complete this crucial task.
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Innovative Design Orthopaedics Ltd. (IDO) is a UK-based company specialized in the development of orthopaedic devices for practitioners in orthopaedic surgery. IDO was established in 2009, and with a team of young dynamic professionals and first-class orthopaedic surgeons, such as Professor Ofer Levy, the company has designed products to meet healthcare professionals’ needs.
IDO reached out to us to review their instructions for use (IFU) of their Verso Reverse Shoulder Prosthesis. This medical device is intended for total shoulder arthroplasty and has successfully been implanted in thousands of patients all over the world in the last decade.
Different Risk Classifications Require Different Translation Processes
The Verso Reverse Shoulder Prosthesis, as a Class III medical device, requires highly specialized professionals not only in the operating rooms but also on the paper.
The IFU includes implant parts, device description, precautions, adverse effects, MRI warnings etc. IDO decided to leave the translation up to orthopeadic surgeons, but trusted in AbroadLink to review and edit their instructions for use.
So, there were three main challenges:
- Text type: Strict EU-guidelines for IFUs and medical devices
- Regulation compliance: Translation procedure in QM system + harmonized terminology for product commercialization
- Medical terminology: Highly specialized for professional use only
In this case, the MDR and IVDR legislation as well as the EMDN/GMDN terminology were applicable. AbroadLink continuously creates and maintains language resources based on the official EU-legislation in form of term bases, glossaries and translation memories. Our project managers always provide the translators with the relevant documentation for medical translation a priori, which is then thoroughly reviewed during the internal QA process at the end of each project.
IDO agreed to AbroadLink’s proposed collaboration with their local distributors to build a multilingual technical glossary. This process consists in selecting specific technical terms with their translations and sending that list to the local distributors for approval. This way, manufacturers have an additional and transparent quality control over translation and, with the distributors’ approval, IDO can discard any linguistic barriers for selling their product in the corresponding country.
Furthermore, with every medical translation project, AbroadLink delivers a Translation Certificate. It does not only guarantee transparency, but may also be used by the manufacturer as record for their specific QMS.
For IDO, we prioritized professional translators with orthopaedic/medical background (doctors, surgeons, orthopeadicians, professional translator with medical translation training) due to the high level of specialization required. At AbroadLink, medical translation work is performed by professional linguists translating into their native language and selected by the procedure specified in our ISO 13485 implementation, which assures the medical specialization of translators.
For this project we worked with Track Changes throughout the IFU in MS Word, so that the client and distributors were able to detect each and every change made by the linguist in the editing process of the original document.
The final and approved translations were then sent to our DTP specialist who took care of the layout. The difficulty was the space limitation of two pages for seven languages as well as inserting correctly the languages with non-Latin alphabets like Arabic or Greek.
Despite the challenges, with the collaboration of IDO, their distributors, our project managers as well as language and DTP providers, we were able to deliver an IFU which meets the expectations of surgeons, authorities and patients.
In the coming years, IDO will help even more people in many more countries regain their mobility, and we are honored to be a part of this journey.
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Alejandra Keller is a German and Spanish native speaker with a high level of proficiency in English. She holds a translation degree from the University of Heidelberg and has lived and studied in Germany, the United States, Ireland, Spain and Peru. With a strong passion for international communication, she is currently working as Project Manager at AbroadLink.