Wireless and Risk Management – Presented by Steven Ferguson. Directive 2014/53/EU includes provisions to address risk management and requires that the file include this analysis. If using a harmonized standard or Notified Body (NB), the risk analysis remains a necessary function and must be present in the technical file. This class reviews the various topics associated with wireless device approval and how to manage risk mitigation. A general approach to documenting the risk analysis included. The review goes beyond the minimum elements specified in the directive to address other matters integral to the overall performance of the device.