Training
Introduction to the ISO 14155
Qserve Medical Device CRO and Consultancy offers you a hands-on GCP course that supports your everyday clinical operations and quality issues. Our course is set up, especially for professionals in the medical device industry that work on clinical trials, PMCF studies, and investigator-initiated trials (IIT), on a regular basis. During this 2-day course, the content of the ISO-14155 GCP standard for medical devices will be our guide. During the interactive sessions, we will discuss the practical implementation of the standard. The theory will be supported by real-life examples of difficulties and mistakes on the one hand, but also practical and clever solutions that avoid unnecessary bureaucratic burdens on the other hand. At the end of the day, you will go home with knowledge, GCP skills, and practical ideas to implement directly within your organization, and you will receive your personal GCP certificate.
Who should attend?
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.
Costs
We offer open enrolment, on-location, train-the-trainer formats.
Please contact us to schedule in-house training, which is also recommended for training multiple colleagues or teams at the same time.