P-10 Clinical Investigation Procedure

P-10 Clinical Investigation Procedure


SKU: P-10 Category: Tag:


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.

The new version of ISO 14155 includes the requirements of the EU MDR and helps the manufacturer in the conduction of clinical evaluation according to all the applicable regulations and guidelines.

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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