Medical device clinical investigations according to ISO 14155

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.

Course description

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.

Course outline

• Clinical investigations according to ISO 14155
• Investigator led investigations
• Practical tips and advice on what to focus on
• Case-studies to apply your new knowledge
• Post-market clinical follow-up (PMCF)
• In vitro diagnostic investigations
• Register and other types of studies
• How to plan, perform and document

Learning objectives

• Introduction t how to design your investigation based from the clinical evaluation
• Basic understanding of how to collect clinical data through medical device investigations
• Overview of procedures of the clinical investigation such as initiation visit, data management and writing the study report
• Hands-on practical tips for how to perform the clinical investigation
• Training on key study documents (CIP, IB, CRF etc) format and what mistakes to avoid
• Introduction to quality checks, CRO oversight and how to check study documents

Who should attend

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.

Prerequisites

Working at least 1 year within the field of medical devices/IVD or related life science field

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