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.

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