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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Analysis of FDA draft guidance "Decentralized Clinical Trials for Drugs, Biological Products, and Devices."
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Strategies to maximize outcomes for interactions during regulatory pre-submission meetings using 4 simple, but effective steps.
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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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Summary of UK Medical Device Brexit Implications including high-level key points of the MHRA post-Brexit implementation plan.
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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The FDA released a new Cybersecurity draft guidance on April 2022.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 The draft guidance significantly expands requirements for cybersecurity activities and documentation for medical devices.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.
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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.
