Specialised in challenging translations for effective market launches

Experienced and certified native-speaker subject-matter experts and technical translators, revisers, reviewers and editors from the relevant specialist areas of medical devices and in-vitro diagnostics will work on your documents with the goal of making sure the product is objectively, technically and terminologically appropriate for the intended use and its target group.

For your company’s international presence, our translation workflows and language experts make it possible for your products, content and websites to be culturally adapted and made available in a meaningful way in the local language.

So we can offer comprehensive customer-specific solutions for all areas such as

Research and development
Registration and certification
Quality management
Clinical evaluations and trials
Quality assurance
Marketing
IT
Training

as well as all other areas for which there is a need for translation and communication.

New guidelines, standards and regulations for medical devices and in-vitro diagnostics

periti’s comprehensive range of services allows us to provide regulatory adjustments as well as translation solutions for your registration documents and clinical evaluations / trials and in compliance with the

Medical Device Directive and Medical Device Regulation
(MDD, AIMDD, MDR)
In-vitro Diagnostics Directive and Regulation
(IVDD, IVDR)
EU, ISO, DIN, CRF and IEC regulations etc.

As a DIN EN ISO 17100 and 9001 certified language service provider with in-depth specialist knowledge, we are known for high-quality translations and, even when delivery times are tight, for adherence to your deadlines.

• Product information,
• Instructions for use (IFUs),
• Labelling

The EU requires precise linguistic information and content conformity for Instructions for use (IFUs) and labelling with the new MDR and IVDR for all markets.

Instructions for use (IFUs)

According to the new organisation, IFUs are of paramount importance because they have to be submitted to the Notified Body or respective authorities for registration as part of the Technical Documentation (device master file) together with the labelling.
The approved IFUs must be available to users in the respective EU languages on the manufacturer's website.

periti helps you master regulatory reviews and meet the new regulations

Adaptation of medical devices/in-vitro diagnostics registered pursuant to the MDD/IVDD to the MDR/IVDR

• Analysis of your IFUs in terms of the new MDR/IVDR
• Checklist and support during the adaptation phase
• Adjustment of IFUs to the applicable requirements

The periti experts for medical devices/IVDs know all the new requirements and will adjust your documents to meet the new rules. If in doubt, please don’t hesitate to contact us for more detailed information on this comprehensive and topical issue.

The right language for every target market

Product information and instructions for use as well as the labelling are required in the national language of the EU Member State where the product is to be marketed.

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

These linguistic impacts demonstrate the important role of professional translations in adapting to the new EU regulations of the MDR and IVDR.