This document is the management procedure (SOP) that describes the clinical evaluation process that the Manufacturer must implement and maintain to collect, analyze and evaluate the clinical data of the device in accordance with MDR/IVDR and international requirements.
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The information contained on this page and in the documents referred to is valid and current as of 07/17/23. Legislative and regulatory provisions are subjec to change and updating by the Regulatory Authorities. This being said, the writer declines all responsibility for any possible lack of topicality and/or accuracy of the information that may have occurred at the same time as or following the publication of this page and the documents referred to. Disclaimer
