Achieve a consistent methodology across the organisation and get through every audit.


Reduce costs, time and effort.


Offer accepted solutions to close gaps


Facilitate the closure of inspection gaps.

An ISO-certified quality system.

Lack of expertise in planning and executing audit activities can lead to delays in validation and severely impact audit readiness. Achieve a consistent methodology across your organisation with Entourage solutions.


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Case Studies.

Implementation of the upcoming registration of global dossiers for worldwide approval of IVD products.

The client has to implement global dossiers for worldwide approval of IVD products for an upcoming registration in a few months. For this purpose, the existing product portfolio must be classified according to the new IVDR and a gap analysis for the technical documentation of the IVD products must be carried out.


  • Facilitation of worldwide registration through uniformly created global dossiers
  • Searching for individual data and documents is no longer necessary. Registrations for large product portfolios can be processed quickly and easily
  • GAP analysis and product classification facilitates the implementation of the new IVD Regulation. Capacities and resources can be easily defined for the transition to the new regulation