To understand the content and role of the ISO-14155 standard in clinical investigations.
To be able to implement the standard in a practical way during preparation, execution, and evaluation of clinical studies with medical devices.
To learn from real life examples that we come across in our everyday CRO and consultancy practice. Allowing you an exclusive look behind the scenes of several example trials.
Patient safety; Data quality; Practical approach; Good documentation practice; Site selection, communication, and collaboration; Clinical strategy.
Clinical and regulatory personnel working at a medical device manufacturer, who are involved in the preparation, execution or evaluation of clinical investigations with medical devices.