Solutions for MDR and IVDR compliance - RWS

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.
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MDR and IVDR compliance verification

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IFU verification and optimization

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In-country review management

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Certificates of accuracy

RWS

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.
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Convergence — Where Medical Device Regulations Meet Pharma

Our specialized solutions help you:

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Reduce risks
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Navigate the regulatory landscape
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Scale with confidence
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Improve process efficiency
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Speed up time to market
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Improve user experience
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Guarantee greater brand consistency
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Reduce translation costs
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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.
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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
  • Labelling
  • 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.
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