The Gap Analysis service enables a company manufacturing medical devices or IVDs to understand whether the technical documentation for its devices, which is currently drafted with the requirements of the Medical Devices Directive or the IVD Directive in mind, also complies with the requirements of EU Regulations 2017/745 and 746 and, if not, what documentary adjustments are necessary.
The service is useful for all organisations that act as a manufacturer of medical devices or IVDs and need to ensure full documentary compliance of their products with the new legal requirements imposed on the sector.
