An NSF International Company M6 - CE Post Market & Vigilance - Product Surveillance and Vigilance for CE Marking of Medical Devices (QP)
PrintPart of Medical Devices QP Training Module 6
£735.00 exl VAT
About this course
This one day interactive course provides you with the simulated practices for interpreting adverse events and product quality trends in order to determine if vigilance action and reporting are required. Understanding whether adverse information requires vigilance action can often be more complicated than the basic requirements infer. In particular we cover the issues of understanding whether the product contributed to the adverse event, and the potential difference in interpretation from EU competent authorities. Within the course we examine periodic reporting, utilizing risk management as a means of informing vigilance action to regulatory agencies, and look at the potential impact of the EUDAMED database on the registration and sharing of data between agencies.
Who Should Attend
Aimed at all professionals managing a medical device placed on the market and involved in any post market surveillance and vigilance, QMS feedback, clinical follow up and vigilance decision making activities. Authorized representatives and distributors will also find this module highly applicable to their function as critical operators within the supply and post market support of medical devices.
