This session will provide a forum to discuss some of the challenges facing manufactures when they submit MDR Technical Documentation to the Notified Body for CE certification. The aim is to share experiences and to discuss some of the best practices that may avoid Notified Body questions and non-conformities.
Learning Objectives:
To gain an insight into some of the key issues identified by Notified Bodies during MDR Technical Documentation assessments.
To gain an insight into the mind of an auditor and how they audit.
To identify ways in which technical documentation can be improved to support a succesful certifcation outcome.