Organised by IPEM's Rehabilitation and Biomechanics Special Interest Group The development of medical devices, including software, must incorporate comprehensive risk management processes, in order to provide assurance of the product’s reliability and safety for clinical application. The aim of this one-day symposium is to highlight and reflect on risk management principles and practices for medical devices. Relevant considerations are:1. identifying the key risk management processes for medical devices 2. relating those processes to other regulatory requirements such as the new EU Regulations for medical devices (MDR) 3. exploring the connection between risk management processes as detailed in ISO14971 and quality management systems such as ISO134854. understanding compliance requirements with regard to custom-made medical devices5. discussing challenges in implementing risk manamgement processes in practice Learning Outcomes1. an understanding of risk management processes for medical devices as detailed in ISO 14971 2. an understanding of the different regulatory requirements regarding risk management of medical devices Target AudienceClinical scientists (including STP trainees), rehabilitation and biomedical engineers, medical physicists, managers, academia, and industry. Registration On-line registration will open soon. Registration deadline: 14th March 2019Conference Resources The provisional programme and abstracts will be available here in due course.Presentation slides will be available after the event here (IPEM Members only - login required)Venue This conference will take place in central Sheffield, details to follow. Contact/QueriesIf you have any queries, please email the IPEM conference team or tel: 01904 550598.
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