Quality-Related Processes

Manufacturers should establish and document a Risk Management Plan (RMP) and a Quality Management System (QMS) for each MD or IVD. To ensure quality compliance, periodic MD/IVD-related audits should be carried out.

How can DDR help?

  • DDR will help identify foreseeable hazards and select the right measures to minimize them.
  • DDR will manage and arrange MD/IVD-related audits with top auditing companies during preparation for certification by a Notified Body.

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