Clinical Investigation became essential for medical device validation and for providing demonstration on the safety of the device on the market. With the EU MDR 2017/745, new requirements were introduced and nowadays a big focus is given clinical studies and clinical evaluation during CE marking process.
Here at QualityMedDev we show an example of Clinical Investigation procedure, fully compliant with EU MDR 2017/745, with details explanation of all the documentation to be prepared before, during and after a clinical study.
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