Medical Device Regulation MDR

What does the MDR include?

In the manufacturing of medical devices, the health and safety of patients is the top priority. To ensure it, there is the EU Medical Devices Regulation, which sets strict requirements for the development, manufacturing, labeling and monitoring of these products.

This regulation also has an impact on technical writing, as a number of specific rules (e.g. with regard to content, structure or even actuality) are laid down in this regulation for the creation of technical documentation for medical devices.

Not only archiving, but also retrieval

You are certainly familiar with the most important requirement of the Medical Devices Regulation MDR that your technical documentation must be archived for up to 15 years. However, the real challenge is not the pure archiving, but the retrieval of the content. With the metadata used in the CCMS TIM, all your content and documentation receives additional information, which makes it easy and fast to find again. And it doesn't matter by whom and when the information was archived.

The all-round carefree package

You want to be accompanied on your way to MDR compliance, but not via an unnecessary detour? We offer you an all-round carefree package with goal-oriented consulting and the appropriate software solution. Thus, we not only work together towards MDR compliance, but also prepare you, your processes and content for working with our CCMS TIM.

Further Solutions

  • Variant management

    Variant management for your company's technical writers. TIM enables you to develop complex product variants in a time-efficient manner.

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  • Smart documentation

    Focus on the future of technical documentation and use your information for smart documentation for your company.

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  • Automation in technical writing

    Automate your technical writing. The CCMS TIM supports you in making recurring workflows easier. Learn more now!

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