Do you work with medical device development and manufacturing? With the new MDR regulations different types of clinical data are allowed- collecting them via investigations is one of them, the other two is via peer-reviewed scientific publications and postmarket surveillance/post market clinical follow-up. Throughout the course we will use case-studies to integrate the guidance with the real world. In addition, you will gain a greater understanding for how the clinical investigations takes a part within the technical documentation and the importance of risk analysis. Today it is not uncommon to collect data via investigator led investigations on a device; how to handle this in a useful way will be reviewed.
The course is aimed at anyone working with development or manufacturing of medical device/IVD and with the need to understand how to collect clinical data through investigations. The course will start with basic info but will give in depth details on the key points. After participation you will know which questions to ask, which quality you should request and how to link with the rest of the technical documentation.
The course is aimed at anyone working with development or manufacturing of medical device/IVD and with the need to understand how to collect clinical data through investigations.
Working at least 1 year within the field of medical devices/IVD or related life science field
This course is available as an In-House Training course. Let us know if you wish to customize a course or if you are a large group with the same requirements.
Leading specialist with long experience of training are guiding you through regulations, guidelines, interpretations, requirements and applications.
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