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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FDA cybersecurity requirements for medical devices which are considered “cyber devices”, including US government definition.
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Overview of eSTAR, a joint Health Canada and FDA program streamlining medical device submissions with info on how to apply for the program.
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Medical device product definition tips ranging from general guidelines to regulatory, reimbursement, and hazard management.
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Engineering and QA/RA leaders share new technology, regulatory and supply chain developments that will impact future medical devices.
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The risk management approach
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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FDA DHT Clinical Investigations examines the latest FDA draft guidance on Digital Health Technology for remote data acquisition in clinical investigations.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.
