Organised by IPEM's Rehabilitation and Biomechanics Special Interest
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 workshop is to highlight and reflect on risk management
principles and practices for medical devices, particularly in the light of the
new Medical Devices Regulation regarding in-house and custom-made manufacture.
Relevant considerations are:1. identifying
the key risk management processes for medical devices; 2. exploring
the connection between risk management processes as detailed in ISO 14971 and
quality management systems such as ISO 13485; 3. relating
those processes to regulatory requirements such as the new EU Regulations for
medical devices (MDR);4. understanding
compliance requirements with regard to custom-made medical devices; 5. discussing
challenges in implementing risk management processes in practice.
understanding of risk management processes for medical devices as detailed in
ISO 149712. an
understanding of the links between the risk management standard ISO 14971 and
the quality management standard ISO 134853. an
understanding of the different regulatory requirements regarding risk
management ofmedical devices.
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