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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5 FDA Inspection tips from our QA/RA experts help make FDA inspections efficient, effective and successful.
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How QA/RA provides value to medical device project development projects and helps support Product Development and Manufacturing teams.
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5 reasons Human Factors remain important in medtech despite technological advancements like Artificial Intelligence (AI).
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Analysis of FDA draft guidance “Decentralized Clinical Trials for Drugs, Biological Products, and Devices.”
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Review of April 2023 FDA draft guidance on PCCP Recommendations for AI/ML-Enabled Device Software Functions.
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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.
