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.
This course will 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).
All prices shown are exclusive of VAT which will be added at checkout.
| Level | Technical |
|---|---|
| Partner Details | ETHOS Ltd Stuart Harrison led the Clinical Safety movement in the NHS alongside some of the most prominent Clinical leaders for over 15 years. Stuart has refined NHS Clinical Safety & Risk Management Systems, re-authored NHS safety standards using plain English campaigns, and worked at the highest level to ensure core safety engineering principles are embedded in the NHS code of practice. These are the foundational principles on which health informatics will be led throughout coming decades and he is passionate about driving at scale improvement across the sector, both in the UK and internationally. His PhD studies at the Institute of Digital Healthcare, University of Warwick are focused on: clinical decision supporting systems including safety concepts for emerging technology & complementary regulatory frameworks and also the inclusion of mobile health data into safer decision making, exploring the lifecycle models of clinical decision supporting systems. |
| Type | Course |
• 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.
• 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).