Regulatory Affairs

Regulatory Affairs

Technical Documentation Europe

Preparation of technical documentation for Medical Devices

Many manufacturers perceive the creation of Technical Documentation as a necessary evil. If you don't act carefully in this process, you risk time-consuming and costly follow-up questions and additional charges.

The three most frequently asked questions when creating the Technical Documentation:

  • What are the additional requirements for Technical Documentation according to the MDR?
  • Is there a format template or a kind of sample structure that can be used as a guideline?
  • Is Clinical Evaluation/Performance Evaluation needed?
 

There are many questions and problems around technical documentation, especially when switching from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR). We have a solution: The qtec Aktenfuchs!

The qtec Aktenfuchs +49 451 808 503 60

The structure of technical documentation

It is not necessary, nor helpful, to submit all the documents "that you have". Technical Documentation only contains documents that are needed and explicitly requested.

There is no mandated structure for the Technical Documentation. However, there are requirements for this structure, which are also described in Annex II of both regulations.

However, there are formats, such as the STED format, which can be used. However, it is not wrong to create your own structure as long as it fulfills the requirements in Annex II.

Depending on

  • in which target areas a company operates,
  • which portfolio is available and
  • how dynamic the product development of a manufacturer is,

various solutions for structuring and formatting Technical Documentation to keep the maintenance effort as low as possible and to avoid anxiety.

We create your structures

Wouldn't it be wonderful to have a structure in which you can store all information and documents, which is easy to maintain and at the same time "reusable" in different target markets? There is! And the best thing is: you don't have to adapt to the structure, we adapt it to you - to your portfolio and your target markets.

Contact +49 451 808 503 60
 

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