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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FDA DHT Clinical Investigations examines the latest FDA draft guidance on Digital Health Technology for remote data acquisition in clinical investigations.
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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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Open Source Software Medical Devices: Using OSS libraries within a Software System of a Medical Device or In Vitro Diagnostic Device.
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Software is not always the answer in medical device design. StarFish blogs about the use of microprocessors in medical device development.Before committing to a design that includes a microprocessor and software, be aware of the regulatory consequences.