E-Learning for Digital Health Software: Safety and Risk Management

A foundational skills-based course for those involved in developing and implementing digital health technology and software as a medical device.

£ 20 per unit

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Course Overview

This course 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
  • digital health and medical device software lifecycle
  • hazard assessments

The course will examine different aspects of clinical safety and risk management systems through a number of modules:

  • 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.

What you will learn

The course will provide you with learning in the following knowledge domains:

  • 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 technology systems and regulated medical software
  • Understand good practise 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
  • Provide insight into the medical device regulatory requirements for quality, lifecycle development and risk management beyond UK NHS standards, towards ISO 13485 (quality), IEC 62304 (lifecycle), ISO 14791 (risk management)

Who should learn

This course is suitable for both technical and clinical staff who are involved in the design, development, implementation and use of health technology software and medical software either for their organisations or for others as a consultant.