The objective of this project is to integrate EU MDR requirements into the quality system by analysing the differences and implementing a detailed action plan. The approach is carried out entirely remotely, to ensure that Median QMS complies with the new European standards.
2022 - 2024
France
Health and life science
With the entry into force of EU MDR regulations, Median must adapt its quality system to meet nearly 1703 requirements, of which 891 are applicable. The mission consists in thoroughly analyzing existing documentation, identifying discrepancies and developing a compliance matrix. A detailed action plan is then drawn up and presented to the quality teams, with a clear distribution of roles between Apsalys and Median.
The regular review of the action plan, the implementation of dedicated SOPs in terms of labeling, clinical evaluation and usability, as well as the systematic review of the documents provided by Median, make it possible to monitor the evolution of compliance. This organized approach ensures not only strategic alignment with EU MDR requirements but also a continuous update of the gap assessment, thus offering a clear vision of the actions to be taken to achieve and maintain regulatory compliance.
The customer is looking for a comprehensive and structured compliance solution that integrates all EU MDR requirements into the QMS. The focus is on a detailed analysis of existing documents, the definition of a shared action plan, and the ongoing updating of the compliance matrix. The remote approach must allow organizational flexibility while guaranteeing accurate and regular reporting on the progress of corrective actions, thus ensuring the reliability and sustainability of the quality system.
Systematically analyze the differences between the current system and EU MDR.
Define a shared and regularly updated action plan.
Ensure regular reporting to monitor compliance progress.
The mission focuses on the comprehensive analysis of the gaps between existing documentation and EU MDR requirements, followed by the design and implementation of a specific action plan. It requires close collaboration between the Median and Apsalys quality teams, the constant updating of the compliance matrix and the revision of procedures. The objective is to deploy corrective actions that guarantee complete and sustainable compliance of the QMS system.
Identify and document any deviations from EU MDR requirements.
Develop and present a detailed action plan to the quality teams.
Implement SOP procedures to strengthen compliance
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