Is your technical documentation already MDR-compliant?

We support you in creating the technical documentation, taking into account the MDR. Find out more about our flexible consulting offer and choose the service that suits your status quo.

Evaluation of your technical documentation for completeness and plausibility
Assistance in revising your technical documentation (after audit deviations)

Gap analysis of your technical documentation

We recommend a detailed gap analysis of the technical documentation as part of the MDR. The focus is on providing you with a strategy on how to efficiently set up and meet the regulatory requirements over the entire product life cycle.

The gap analysis of the technical documentation essentially includes the following services:

Allocation of the existing verification documents to the requirements
Evaluation of the content of the existing verification documents
Description of Findings
Joint evaluation of the results
Definition of the necessary measures
After the analysis, our help is not over. On request, we can provide you with an electronic system with a prepared structure for the technical documentation. We help you to get an overview of what is missing in your technical documentation and work with you to take a structural approach to the MDR and its strict requirements.

We can support you in creating such technical files from scratch.