Manufacturers should establish and document a Risk Management Plan (RMP) and a Quality Management System (QMS) for each Medical Device (MD). To ensure quality compliance, periodic MD-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-related audits with top auditing companies during preparation for certification by a Notified Body.