Technical Documentation and Labeling according to the new EU Medical Device Regulation:
- Product Information will have to be clear and searchable for the user.
- Instructions for Use (IFUs) and Labels will also have to be available in local languages.
- You will have to word IFUs so that a layperson can understand and apply them.
- Information on labels should comply to regulatory requirements
- As an excellently experienced agency with more than 3,000 readability user tests, we also provide readability testing services on the basis of the Guidelines
- EU languages Mandatory_Languages_Requirements_for_Medical_Devices.pdf
- EU Guideline on the Readability of the Labelling and Package Leaflet of Medicinal Products for Human Use, Revision 1, 12 January 2009
- Provides translation services in all European languages
- Conducts an evaluation of the labeling of medical devices according to MDD 93/42/EEC Annex I, MDR 2017/745 Annex I, MEDDEV 2.4/3, EN ISO 15223-1: 2016, EN 1041 and the local legislation
Translations for all aspects of the registration of medical devices and
in-vitro diagnostics, as well as for all internationalisation projects
Localisation is an absolute prerequisite for successful global product marketing. Therefore the bulk of any internationalisation process involves translation and localisation tasks, and they serve as the basis for any globally successful product.
Consequently, these tasks are considered the highest priority in all orangeglobal projects and are efficiently integrated into the workflow.
The orangeglobal group is able to utilise state-of-the-art methods and processes thanks to the cross-departmental expertise of its organisation, in which marketing authorisation experts working together with linguists professionally analyse and organise medical language processes.
Translations for medical technology, dental technology and laboratory technology
Quality doesn’t happen by chance - only a well organised translation is also a professional translation.
The orangeglobal group has made this approach its top priority when it comes to organising and carrying out product-specific language processes.
Quality can only be assured by a process optimally adapted to customer and document requirements that far exceeds conventional standards, using all necessary subject experts and systems and with standardised implementation, including SOPs. The orangeglobal group’s business model is organised around the idea that the different departments (Regulatory Affairs, Pharmacovigilance, Studies and Marketing) with their scientific experts work together in an interdisciplinary manner with the translation and language department.
Obtaining translations of the highest quality eliminates protracted correction loops on both sides, which traditionally involve significant costs and can complicate the submission process considerably. At the same time, the systems used as part of this process guarantee not only improved quality, but also permanent cost reductions for every project or product.
Harmonisation and optimisation starts with conducting a potential analysis of your current situation and will be defined and monitored in a joint goal-setting session involving precisely defining milestones and results.
Your specialist for translating medical devices and IVDs and their marketing authorisations
The orangeglobal group uses its subsidiary mpü translations to do medical translations and to carry out all corresponding language processes. mpü is the specialist for technical translations for medical devices and IVDs. mpü translations naturally offers all of the services typically provided by a cutting-edge language service provider specialising in the healthcare industry while also maintaining the highest safety standards.
In addition to the latest language technologies (CAT tools, terminology databases), we also use testing and validation tools developed in-house for specific quality checks appropriate for the document type. We develop, in consultation with our experts in the competence centres of
Regulatory Affairs | Labelling | Studies | Marketing | IT | Language Management | Multilingual DTP Service
your product- and company-specific processes.
We are your partner for subtasks, single translation or process stages or your entire project and process flow.
Translation for clinical trials and assessments
As an ISO 9001:2015 certified provider, we will help you with translation and localisation processes for
all documents before, during and after a clinical trial.
Our translation management for clinical trials is focused on on-time, error-free completion of your projects in accordance with GCP guidelines, adapted to your study plan and in line with regulatory requirements:
- Preclinical and clinical research
- Clinical trials
- Post-marketing surveillance
- Clinical trials for medical devices
- Performance evaluations for in-vitro diagnostics.
Translations for registration of medical devices and IVDs
Our translation and language management system for regulatory affairs focuses on the on-time, error-free completion of your projects, including compliance with the relevant regulatory or procedural directives, such as:
- Symbol templates
- FDA, MPG and WHO requirements
- ISO and DIN standards
- Check for national regulatory requirements such as HAS, ANSM, etc.
Translations for labelling of medical devices and IVDs
Because the orangeglobal group provides a comprehensive, interdisciplinary range of services, it is able to offer a process specifically for labelling translations that meets all time management and safety requirements, and that ensures acceptance by the authorities.
- Tried and tested process for labelling translations
- Prompt delivery within the defined time frames
- Take into account all official EU specifications such as
• IMDRF requirements (label and instructions for use for medical devices)
• ISO standards for IfUs: IEC 82079
• Checking for international norms and standards, e.g. symbols pursuant to European
standard EN 980 or ISO 15223:2012
- Take into account all official FDA requirements such as
• Device Labeling Guidance
• Labeling 89-4203
• “Write it right” and “Human Factors Principles for Medical Device Labeling”
- Various service packages depending on the regulatory requirements or processes
- Consistent quality and cost-efficiency by using the latest software, labelling terminology databases,
quality assurance tools, testing and validation tools
Translations for marketing purposes
Perfect marketing communication on a global scale - transcreation instead of just translation
Whether in print or online – whether for translation, transcreation or localisation – our processes are specifically geared to the requirements of the medical technology industry, always in combination with the necessary creativity and focusing on the relevant local target group so that sensitive messages are transferred into the other language exactly as intended:
- Transcreation: Creative, content-based, marketing-oriented localisation of claims, advertising messages, etc.
- Creative and medical writing, also reviews
- Visual localisation of layouts, artwork, etc.
- Multilingual desktop publishing
and much more…