Clinical Safety & Risk Management

The Institution of Engineering and Technology - IET

Course summary

14 hours

240 GBP excl. VAT

Flexible

Online courses

Next available date: Start anytime - Online courses

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The Institution of Engineering and Technology - IET

Professional Training

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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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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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The Institution of Engineering and Technology

The IET provides world-class online training for engineers at all career stages. E-learning has never been so important. Browse our courses below to find training that you can complete anytime, anywhere through the IET Academy. From soft skills and professional...