TECHNICAL DOCUMENTATION at a glance
According to your needs, our activities include the following aspects.
Projekt Kick-off
First of all, we will define with you the scope and strategic approach and agree on a timeframe, including relevant deadlines that must be met.
The exchange of all necessary information is initiated.
Gap analysis
We review your Technical Documentation regarding compliance with MDR requirements in the level of detail demanded. The associated documents are reviewed. Existing gaps, both in terms of form and content, are identified and transparently documented. We work with you to develop an efficient strategy and jointly define measures to close any gaps.
Preparation of Technical Documentation
Complete and MDR-compliant Technical Documentation is a prerequisite for product approval. We identify the regulatory requirements and support in creating and setting up your Technical Documentation in order to prevent time-consuming and cost-intensive deviations and review cycles by your Notified Body.
Support for the elimination of deficiencies
Do you need support in dealing with deficiencies identified by your Notified Body? Together we develop an efficient strategy and possible solutions to resolve these deviations.