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    Explore the Convergence of Global Regulatory Trends Impacting Quality Management Systems

    The new and changed requirements for a risk management system according to the third edition ISO 14971:2019 and Regulation (EU) 2017/745 on medical devices will influence the technical documentation through the medical device lifecycle. Further, the clinical evaluation requirements according to the Regulation (EU) 2017/745 and the MEDDEV 2.7/1 rev. 4 is a substantial part of the technical documentation, which has significant influence on the approval and certification. The core of the clinical evaluation is based on pre-clinical and especially clinical data to support the safety, performance and clinical benefit of the medical device. Clinical data can be obtained from clinical investigations, scientific literature or clinical experience data. In addition, ISO 13485:2016 now has a specific requirement for Post Market Surveillance (PMS) as well as several new PMS requirements found in Regulation (EU) 2017/745. The correlation between risk management, clinical evaluation and other post market surveillance activities will call for some substantial changes within the Quality Management System in order to comply with new Global Regulatory expectations.


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