An NSF International Company M6 - CE Post Market & Vigilance - Post Market Surveillance Plans for CE Marked Medical Devices (QP)
PrintPart of Medical Devices QP Training Module 6
£1470.00 exl VAT
About this course
Unless you have been in a land far-far away you will be aware of the additional scrutiny of CE marked products and in particular the methods of adopting appropriate product surveillance plans and subsequent data analysis in order to provide early warning of product safety and quality issues. This course takes you through the notified body and competent authority expectations for post market surveillance and applies a case study approach for a series of different types of devices including the obvious implantable products but also covering woundcare, infusion pumps, electro-medical diagnostic devices and single use instruments.
Moving from the basic regulatory requirements to establishing best in class trending data from internal and external sources, we will equip you with the necessary insight towards adopting a fit-for-purpose post market surveillance plan and introduce you to the necessary quality management system procedures, data collection methods and state-of-the-art methods to maintain a robust, cost-effective and highly informative analysis that will inform your regulatory compliance.
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.
