Robert-Walser-Platz 7
CH-2503 Biel
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The technical documentation (TD) is an essential part of a medical device and a core element of the submission dossier. The TD is based on the regulatory strategy of our customer and in cooperation with the Regulatory Affairs department (according to NB-MED/2.5.1/Rec5 and/or 21CFR820 DHF/DMR/DHR).

Accompaniment product CE marking

The Notified Bodies (NB) usually examines the required technical documentation for CE marking a product. ISS provides the following services to receive the CE marking for a product:

  • Determination of the TD structure
  • Analysis of the existing TD, and documentation of existing gaps in the information (Gap analysis)
  • Definition of concrete proposals for compiling the TD and the path to successful CE marking
  • Preparation and accompaniment of the audit through the NB
  • Processing of uncertainties and deviations needed to be addressed by the NB