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