For many IVD manufacturers, the requirements for the quality management system have changed with the IVD Regulation. As one of the first steps in implementing the IVDR, you should therefore check which requirements are now placed on your QMS. Among other things, it should be noted that the new version of EN ISO 13485:2016 has already been mandatory since mid-2019.
Internal audits with Metecon auditors have proven successful for our customers because we prepare you optimally for QM audits: We uncover possible weak points, determine the effectiveness of your QMS and help to implement appropriate measures accordingly. In this way, you prevent deviations by your notified body.
The results of an audit are an important building block for your management review. We would be happy to discuss with you the benefits, the process and the effort required for an internal audit. Learn now how internal audits work with us