Digital Health Software Safety and Risk Management Unit 3: Safety Engineering and Risk Management- Methods
This Unit explains the method and lifecycle of a clinical risk management system. With the aid of a safety engineer who can work closely with the clinical safety officer you will understand the basics of the lifecycle in which risk analysis, evaluation and control can be applied and documented.
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Stuart Harrison has led the Clinical Safety movement in the NHS alongside some of the most prominent Clinical leaders for over 15 years. He 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 codes of practise.
Stuart's background is engineering, particularly safety critical industries where safety has immediate risk to harm to system users or the wider general population. He was one of the original authors, reviewers and implementers of the clinical safety standards over ten years ago. Stuart led the review into the implementation and effectiveness of clinical risk management and its relationship with design and assurance across the organisation and wider NHS. Having rewritten both standards as part of an independent consultation, and restructuring their methods provides a more agile model and easier uptake for users – therefore safer systems in healthcare.
• Understand the areas of equivalence in the medical device regulations for software as a medical device. As this will be covered in more detail in subsequent units.