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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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FDA DHT Clinical Investigations examines the latest FDA draft guidance on Digital Health Technology for remote data acquisition in clinical investigations.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.
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Learn about the FDA's 2023 guidance on premarket submissions for device software functions and its impact on the medical device industry.
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The FDA released a new Cybersecurity draft guidance on April 2022. It is intended to replace the current final guidance from 2014 which is well overdue an update. The draft guidance significantly expands requirements for cybersecurity activities and documentation for medical devices. The intention is to align medical device development with current best practices from other industries. This white paper reviews these new requirements and considers their impact on medical device developments.
