The application of risk management to medical devices is addressed by the pivotal standard ISO 14971. In this webinar we explore how risk management is applied in the context of active medical devices, particularly as it relates to patient and operator safety.
Risk management primarily involves identification of hazards and mitigating risk. Some of these hazards are well known and mitigated by the application of relevant standards, which we will discuss in this presentation.
Other hazards require analysis and may overlap several domains of expertise, from medical risks to usability. We take you through the process of ensuring your risk analysis meets the requirements of the relevant standards.
Safety by design and other protective measures are also key risk management features, as well as the use of information, labelling, warnings and training resources.
The topic will be primarily presented by Genesys CEO Geoff Sizer supported by Sue Lynch from MedTech Pathways.
