Implementing risk management into the medical device development process has become a regulatory necessity. However manufacturers still struggle to not only fulfill the requirements of ISO 14971, but also to find ways to implement risk management into the overall operating framework in a meaningful way.
This audio conference discusses the elements of risk management, the regulatory requirements and current interpretations, as well as implementation of a compliant risk management process. Additionally, the presentation will provide practical tips to optimize the benefits of implementing risk management into the development process while at the same time minimizing the administrative burden imposed by the additional process.
This audio conference is presented by Markus Weber of System Safety Inc. To learn more, visit www.fxconferences.com.
