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Endocrine Disruptors in Medical Devices: An Integrated Approach for Compliance with Regulatory Requirements

The goal of the present paper is to propose a systematic, standard workflow for the safety assessment of endocrine disruptors through the understanding of what EDCs are, where they are found and how to mitigate their exposure via the performance of the biological evaluation of MDs, followed by the evaluation of the known EDCs as established by ECHA for the verification of the test method proposed, all in the context of a pragmatic, operational workflow.



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