With our translation expertise, we can help you with every aspect of the registration process, both nationally and internationally
The comprehensive range of services offered by mpü translations for product information and labelling ensures tailored solutions for your registration/approval.
Confidence in the translation workflow thanks to DIN EN ISO 17100 certified language service providers The individual stages of the process in our translation workflow guarantee that all deadlines will be met and your documents will be accepted by the authorities.
Furthermore, all of our processes are geared toward our customers’ specific requirements while adhering to ISO 17100 requirements. This is how we achieve the results you expect and the quality you require.
Product information and labelling
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 include all of the written, printed or graphical information (per the Medical Device Directive MDD, MDR or European and American requirements) about the device such as
Product information/ usage information
- Instructions for use (IFUs)
- Directions for use (DFUs)
- Operating instructions
- Device descriptions and manuals
- Online help, online manuals
- Marketing materials: flyers, booklets, brochures, posters, advertisements, promotional gifts
Labelling
- Printing and writing on packaging, containers, devices, controls and screens (e.g. graphics, symbols, text)
- Labels
Regulations
To exclude risks during use as much as possible, manufacturers must adhere to the specific requirements of the numerous
- EU, ISO, DIN, CRF and IEC rules/regulations and the
- Medical Device Directive and Medical Device Regulation (MDD, AIMDD, MDR) as well as the
- In Vitro Diagnostic Medical Device Directive and In Vitro Diagnostic Medical Device Regulation (IVDD, IVDR)
- when preparing documents for the registration process.
Compliance with the guidelines of the competent Notified Body is also ensured in this process.
This is why mpü’s specific and certified translation process, depending on the need, consistent terminology across all departments and consideration of all international and regulatory requirements, norms and standards in all languages of the target countries are critically important. With its comprehensive range of services, mpü will be there for you every step of the way.
The right language for every target market
Acceptance of a product by users is markedly higher if the instructions for use (IFU) are available in their native language. Different countries require the product information and instructions for use and the labelling in the national language.
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
Feedback loop with country subsidiaries
- Feedback loop with country subsidiaries
- Long-term optimisation of translation quality by using a feedback loop tool with access to
client-specific translation memories and terminology databases
Translations for regulatory documents
The purpose of the product information/usage information is
- Ensuring the safe and correct uses of the product and to make sure the wording is
appropriate for the target group - Meeting the regulatory requirements
- Creating the preconditions for the conformity evaluation
We will help you to create the usage information and to optimise the information management process for your technical editing
- Target-group analysis and usability testing of existing documents
- Planning of document spectrums and editing guidelines
- Structure concepts: modularisation, information typing and single sourcing
- Choosing document preparation tools and processes which are appropriate for the document volume
- Efficient text creation appropriate for the target group in the source language
- Translation-optimised writing: consistent layout, unambiguous language
- Safety information written and designed in accordance with European and American regulations
Why mpü?
mpü is DIN EN ISO 9001:2015 and DIN EN ISO 17100:2016 certified and is synonymous with translation and process management of the highest quality.
- Consulting for process definition/advising, setting up workflows
- Creating a customer-specific process based on the initial situation
- Risk management for the translation process
- Translation of all documents in all languages
- Consideration of all international and local regulatory requirements, norms and standards
- Prompt delivery within the defined timeframes
- Translations by linguistic and subject experts in medicine and medical technology (native speakers)
- Review in accordance with DIN EN 17100 by a second independent language expert
- 3-step quality assurance (QA) system in all languages with special QA processes and tools
- Consistent quality and terminology for current and future projects company-wide
through the use of translation memory (TM) tools, quality assurance tools and
customer-specific terminology databases - Foreign-language DTP and formatting as per the client’s specifications
- Synchronisation/preparation of documents for different products within a product family
- Securing data by using a separate translation server
- Various price/service packages depending on your requirements or processes
