This document is the management procedure (SOP) that describes the pre-clinical evaluation process that the Manufacturer must implement and maintain to collect, analyze and evaluate pre-clinical device data (e.g. safety testing, animal testing) 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
