It is important to start correctly when creating your strategy for the transition to IVDR/MDR. The first step is to identify the activities and processes that are considered either compliant or non-compliant.
Performing a Gap Analysis will provide you with a list of key actions to update your procedures and documentation which we will walk you through.
Under the IVDR/MDR, Notified Bodies will have an increased engagement with manufacturers through conformity assessment procedures, and following the new requirements will be a major challenge for many companies.
Our team of experts will help you cover all the necessary considerations by providing you with the support and accompaniment you need.
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