Recap: Innovator Support Programme Webinars
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Introduction to Software / AI as a Medical Device
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Statement of intended use, and risk classification
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Technical File 1
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Technical File 2 – Clinical Evaluation
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QMS and Post-market Surveillance
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Data Protection and Information security
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NHS regulation of digital tech and Apps, AI Framework
(DTAC, DCB0129, DCB0160)
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International standards and regulatory frameworks
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What’s different about AI as a Medical Device?