Translation solutions for medical devices and in-vitro diagnostics
Regulatory compliance, safe use and linguistic clarity for patients and users
The mpü language solution specialising in challenging translations and an effective translation process from the preparation phase, through to registration and clinical evaluation and on to market launch.
We guide your documentation throughout the whole product life cycle in all subject areas of
mpü – more than translations
Experienced and certified native-speaker subject-matter experts and technical translators from the relevant specialist areas of medical devices, dental technology, laboratory technology and in-vitro diagnostics work in the target countries for you. Our services are:
Document-oriented
Every document is processed by subject-matter experts according to its purpose and target group.
Quality-oriented
Using strictly defined, multi-stage quality standards, we safeguard project outcomes starting from electronic checks to the expert review or regulatory reviews and adaptations.
Expert-oriented
As a benefit, our customers have the option to use our med tech experts on the Medical Device Regulation (MDR) journey, for example with the creation, adaptation or conversion of the documents from technical documentation, product information, etc.
Process-oriented
Streamlined processes for the best solutions. Customer-specific workflows increase the text quality and minimise costs and the time needed. An all-in-one service consisting of DTP, process management, technology management and language efficiently rounds off the workflow. We reduce the work you need to do internally.
We don’t compromise on quality
Adaptation of the product information for medical devices/
in-vitro diagnostics to the new MDR/IVDR requirements
Instructions for use (IFUs)
According to the new Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR), the “Instructions for Use (IFU) are of paramount importance because they have to be submitted as part of the technical documentation (product files) to the notified body or respective authority for registration.
The approved product information (IFUs) must be available to users in the respective EU languages.
These linguistic impacts demonstrate the important role that professional translations play in adapting to the new EU regulations of the MDR and IVDR.
Your products and documents in the best hands
Rely on our expertise in all technical disciplines and product groups for an individual implementation of your project.
Our experienced ‘medical technology’ project team has the expertise and the resources to prepare high-quality translations with the highest level of care even when the delivery deadlines are tight.
Certified
mpü is certified according to EN DIN ISO 9001 for a smooth process and according to DIN EN ISO 17100 for reliable quality assurance for all translations to ensure the quality that your exacting documentation requires.
Service-oriented/personal
Your personal and expert mpü contact is your constant guide for all projects and issues.
Conscientious commitment within a partnership takes priority at mpü for the best implementation of your requests and orders. Transparent processes support the trusting collaboration with mpü.
We support your company as well as possible at all times and find the right project manager from our team
Registration and clinical evaluation of your MDs and IVDs
Translation solutions for successful market access
Thanks to the extensive range of services for medical technology translations from mpü, we achieve the result you are looking for.
We offer
Registration
In all languages quickly and safely in your target market
The product information and labels are required in the national language of the EU Member State where the product is to be marketed.
As part of the product files (device master file, technical file or simply just TechDoc), the product information leaflets and labelling refer to the identification, the technical description and the use of the medical device or in vitro diagnostic medical device.
In other words, they therefore include all of the written, printed or graphical information (per the MDR/IVDR requirements) about the device.
The right target language for every target market
The notified bodies’ language list shows the languages which are mandatory for the product information and labelling in the respective country. MDEG – 2008-12 – II-6.3. Mandatory Languages Requirements for Medical Devices update Sept.08
Precise – consistent – technically skilled
Clinical evaluations/trials
Being well prepared and translating promptly
Translations for clinical evaluations/trials and performance assessments for international registrations.
The European requirements for clinical evaluation, which is reviewed as part of the technical documentation (product file) within the conformity evaluation procedure for medical devices, call for ever more comprehensive clinical data under the new Medical Device Regulation (MDR).
Depending on the class and degree of innovation of the medical device, it is to be expected that the notified body will also want to check the documents that are referenced in the clinical evaluation/trial (e.g. technical documentation, audit reports, evaluation reports and control reports) in all official languages of the target markets.
Therefore, it is recommended to translate all referenced documents into the official language(s) of the Member State in question so as to have them available in case of any queries.
These may for example include excerpts from the following documents
ISO certified translation – for your peace of mind for clinical trials
mpü is certified according to EN DIN ISO 9001 for a smooth process and according to DIN EN ISO 17100 for reliable quality assurance for all translations. We provide the results and the quality that your exacting documentation requires.
Our translation management team for clinical evaluations and performance evaluations is focused on creating a workflow for all process steps pursuant to DIN EN ISO 9001 and DIN EN 17100 that ensures the
Multilingual DTP (foreign language typesetting) for optimal results even after the translation
SAVE TIME WITH mpü FOREIGN LANGUAGE TYPESETTING
Round off your translation order with our skill in multilingual DTP.
We adapt the translation to your layout requirements, take into account the linguistic expansion of the different target languages, our native speakers review the documents used and you receive your IFUs, for example, in your desired final format.
FEEDBACK LOOP WITH COUNTRY SUBSIDIARIES
mpü organises the correction phases with the country subsidiaries, optimising the consistent translation quality across the company and shortening the workflow. There is also less internal effort for you.
