MDR Auditing Process Pre-Application

Auditing process under the MDR Conformity Assessment

What manufacturers of medical devices should know about the pre-application auditing process for MDR conformity assessment

Once you have registered on our website, and resources are available, you will receive our MDR Conformity Assessment pre-application forms. We use the data collected in these pre-application forms to draw up your quotation. Acceptance of our quotation represents the start of the MDR Conformity Assessment application phase, which includes a more in-depth check of your MDR Conformity Assessment application documents.

Overview

MDR Stage 1 Audit (Initial Audit)