Demonstrate they have detailed knowledge and understanding of global statutory reporting requirements including local intepretation and current expectations with particular emphasis on EU and US requirements.
Illustrate they have detailed knowledge and understanding of post market surveillance requirements and development of a post market surveillance plan that is consistent with the risk associated with the device based on its intended use.
Communicate a detailed knowledge and understanding of complaint management including assessment, evaluation and response to post market data.
Demonstrate they have detailed knowledge and understanding of risk management principles and requirements including the role of detailed risk assessment in the evaluation and response to post market data.
Illustrate they have detailed knowledge and understanding of requirements for all types of potential field actions including field safety corrective actions, advisory notices and recalls. This shall include an understanding of the critical components of effective field action management.
Understand the links between CER and risk management and other documetation to proactively incorporate these into routine post market surveillance activities
Analyse and evaluate post market surveillance data within a risk management process to achieve a lower risk/better product, e.g. data from US FDA MAUDE (Manufacturer and user facility device experience) database.
Formulate and communicate a post marketing surveillance strategy which meets appropriate regulatory requirements.