Solutions for MDR and IVDR compliance
The EU Medical Device Regulation (MDR) and In Vitro Diagnostic Device Regulation (IVDR) pose new challenges for manufacturers in creating, managing, translating, submitting and delivering content and technical documentation for their devices – including requiring additional documentation in all 24 EU languages much earlier in the certification process.
Ensure global compliance in all your target markets with our comprehensive services – carefully designed to help you navigate this changing regulatory landscape with greater content control and oversight.
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Ensure global compliance in all target markets
We offer support and advice on improving instructions for use (IFUs) in line with MDR and IVDR, ensuring they are clear, concise, compliant and appropriate for all intended audiences before you begin translation.
MDR and IVDR compliance verification
IFU verification and optimization
In-country review management
Certificates of accuracy
Convergence – Where medical device regulations meet pharma
This paper provides key insights into the latest MDR requirements and how they seem to be aligning with the complex pharma regulatory ecosystem, with linguistic requirements as an integral part of the compliance process.
Our specialized solutions help you:
Reduce risks
Navigate the regulatory landscape
Scale with confidence
Improve process efficiency
Speed up time to market
Improve user experience
Guarantee greater brand consistency
Reduce translation costs
Medical device manufacturer meets objectives and optimizes processes
Find out how the world’s largest healthcare company for dialysis, hospitals and medical care improved MDR compliance and time to market while reducing translation cost for 20+ languages with a streamlined process for managing IFU creation and translation.
Your multilingual content partner throughout the entire product lifecycle
We offer services to support you with all your content and technical documentation in all 24 EU languages – and in 360+ languages globally.
- Technical documentation
- eLearning content
- Labeling
- Post-market surveillance
- Marketing and website content
- Video and audio
- Software and user interface
- Legal and financial documentation
Our tried and tested methods will help you scale up your translation processes efficiently and ensure full compliance with all regulatory requirements – now and in the future.