Digital Health Software Safety and Risk Management Unit 11: Implementation of Class I Software as a Medical Device
This unit explores Implementation of Class I Software as a Medical Device.
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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.
• Exploring the Class I Medical Device certification journey.
• Detailed steps in certification and registry.
• General obligations as a manufacturer.