Über die Veranstaltung

Keywords:
- Medical devices in the field: regulatory framework
- Actors and their roles (PRRC, manufacturer, importer, authorized representative, and others)
- Post-market surveillance (process development and implementation)
- Practical exercise: Post-market surveillance activities
- Vigilance: reporting, recalls/examples, field safety corrective actions, corrective actions preventive actions (CAPA)
- Practical exercise: Incident report as manufacturer
- Advertising medical devices (claims and other regulatory aspects)

Description:
This course provides an overview of the regulatory framework governing medical devices once placed on the market, including the roles and responsibilities of key economic operators such as manufacturers, authorized representatives, importers, and PRRCs. Participants will learn how to develop and implement effective post-market surveillance systems, including vigilance activities, incident reporting, recalls, field safety corrective actions, and CAPA processes. Practical exercises reinforce key concepts, including conducting post-market surveillance activities and preparing an incident report as a manufacturer, as well as addressing regulatory requirements for advertising and claims.