The aim of the course is to identify similarities and differences between the regulations of the FDA and the European regulations for Medical Devices. The focus will be on
Technical Documentation vs Device History File and Device Master Record)
CAPA and Complaint Handling
A Notified Bodiy representative will start the course by explaining the regulatory requirements.
In the further presentations articular attention will be paid to findings made during FDA inspections.
3 Parallel workshops – concentrating on technical documentation, preparing a FDA inspection and audit findings – will provide practical orientation.