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This course provides anyone involved in the development and implementation of digital health and software as a medical device with the foundational skills and awareness to complete their role safely. It provides introductions into clinical risk management, quality, safety engineering and clinical or medical safety officer practices that are equivalent to many aspects of the new medical devices regulations.
Topics covered in the course include safety engineering and risk management methods, delivery and compliance; and digital health and medical device software lifecycle and hazard assessments. The course will examine different aspects of clinical safety and risk management systems through a number of modules, including: post market surveillance, vigilance and service management; mobile apps and innovation; medical device software; data safety; and standards, guidance and best practice with the implementation of AI digital health interventions in the NHS.
Level: Technical
This course is suitable for both technical and clinical staff who are involved in the design, development, implementation and use of health IT software and medical software either for their organisations or for others as a consultant.
Units included in this course
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