Course description
Clinical Safety & Risk Management
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
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Upcoming start dates
Suitability - Who should attend?
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.
Outcome / Qualification etc.
- Understand the technical requirements of the NHS DCB 0129 & DCB 0160 standards.
- Explore emerging NHS requirements for Clinical Safety and medical technology audits.
- Understand the NHS entry requirements for unregulated health IT systems and regulated medical software.
- Understand good practice in health technology clinical risk management and the ability to evidence against clinical outcomes.
- Full awareness of digital health intervention clinical safety and regulatory requirements for innovators & start-ups, SME safety culture in a technology driven business and regulatory insights.
Training Course Content
Units included in this course
- Unit 1: Introduction to Unregulated Health IT Software and Standalone Software as a Medical Device - Pre-order Only
- Unit 2: Clinical Safety and Risk Management Systems – An Overview - Pre-order Only
- Unit 3: Safety Engineering and Risk Management- Methods - Pre-order Only
- Unit 4: Safety Engineering and Management – Delivery - Pre-order Only
- Unit 5: Safety Engineering and Risk Management- Compliance - Pre-order Only
- Unit 6: Hazard Assessment Methods for Health IT and Medical Software - Pre-order Only
- Unit 7: Health Organisation, Implementation, Use and Decommissioning - Pre-order Only
- Unit 8: Post Market Surveillance, Vigilance and Service Management - Pre-order Only
- Unit 9: Digital Health Interventions and Apps - Pre-order Only
- Unit 10: Clinical Safety and Agile Development - Pre-order Only
- Unit 11: Implementation of Class I Software as a Medical Device - Pre-order Only
- Unit 12: Clinical Safety & data - Pre-order Only
- Unit 13: Clinical Safety & Implementation of AI Based Digital Health Interventions - Pre-order Only
- Unit 14: Final Assessment - Pre-order Only
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