Gap Analysis for MDR 2017/745

We will conduct an initial assessment of your existing quality management system (QMS), technical documentation, and regulatory compliance processes to establish a baseline.

Our team will perform a detailed gap analysis to identify specific areas where your current practices do not meet MDR 2017/745 requirements. This includes evaluating clinical evidence, risk management, post-market surveillance, and labeling.

Based on the findings of the gap analysis, we will develop a customized action plan outlining the steps needed to achieve compliance. This includes prioritizing tasks, assigning responsibilities, and setting timelines.

We will provide ongoing support to help you implement the necessary changes, including updating documentation, enhancing processes, and training staff.

We will review and update your technical documentation and clinical evaluation reports to ensure they meet MDR requirements. This includes verifying that all necessary evidence and justifications are properly documented.

Our team will assist you in developing a regulatory strategy and preparing submissions to Notified Bodies, ensuring that your documentation is complete and meets the stringent requirements of the MDR.

We will help you establish or update your post-market surveillance and vigilance systems to comply with MDR requirements, ensuring ongoing monitoring and reporting of device performance and safety.

MDR Audit Support: In addition to all the points above we do support you through your audit to stay compliant with MDR.