Resource Centre
Discover a wealth of knowledge and insights from the experts at StarFish Medical. Our Resource Centre offers product development tips, reviews of new and cutting-edge technologies, and in-depth articles on regulatory updates and compliance in medical device development.
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Summary of UK Medical Device Brexit Implications including high-level key points of the MHRA post-Brexit implementation plan.
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FDA DHT Clinical Investigations examines the latest FDA draft guidance on Digital Health Technology for remote data acquisition in clinical investigations.
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Analysis of QMSR ISO 13485:2016 Alignment in FDA proposed changes to Quality Management System Regulation for alignment with ISO 13485:2016.
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Medical device cyber security: 2022 Update includes review of regulations and implications in an ever-evolving landscape of vulnerabilities.
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Exploration of the potential in using Medical Device AI with tips on how to avoid pitfalls in AI implementation.
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Review of the FDA transition plan for medical devices currently marketed under Emergency Use Authorizations with implications for devices.
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How the FDA Catalog of Regulatory Science Tools can reduce risk in medical devices and explores several tools and categories.
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Overview of the FDA action plan for AI/ML in software as a medical device (SaMD) and list of best practices.
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2021 top medical device commercialization videos cover 2021 updates, optimizing founder value, manufacturing for NPI, IVD insights. and more.
