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Analysis of FDA draft guidance “Decentralized Clinical Trials for Drugs, Biological Products, and Devices.”
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Company values that StarFish employees use most in developing medical devices include looking deeper, cutting to the chase and getting better.
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Medtech trends including AI, UX Design, Device Connectivity, and Sterilization Protocols that might impact your medical device project.
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Commonalities and points of potential confusion of the “big 4” incoherent-light hazard classification and standards for medical devices.
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Considerations for designing UDI labels for medical devices include ANSI/ISO Parameter Values, label verification and durability.
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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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Medical device product definition tips ranging from general guidelines to regulatory, reimbursement, and hazard management.
