MDR Auditing Process Stage 1

What manufacturers of medical devices should know about the planning of the stage 1 audit and the execution of MDR conformity assessments

The stage 1 audit forms part of the initial audit for all first-time applicants for MDR conformity assessment. The stage 1 audit can be conducted on- or off-site depending on the circumstances. In the stage 1 audit, the auditors check whether your company is ready to be audited.