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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  • A man wearing a blood glucose monitoring system on his upper arm sits at a table looking at his smartphone. Bold white text on the image reads, "This changes healthcare forever." A red arrow points to the CGM device, with an inset close-up image of the Dexcom-branded sensor.

    Bio Break: Over-the-Counter Blood Glucose Monitoring Systems

    In this episode of Bio Break, StarFish Medical experts Joris and Nick explore the groundbreaking FDA clearance of the first over-the-counter continuous blood glucose monitoring system. This exciting development marks a significant milestone in the world of diagnostics and opens new possibilities for patient-centered healthcare.

  • SBOM Analysis and Value

    The Value of SBOMs and SBOM Analysis

    SBOM Analysis and Value covers the FDA “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions guidance, role of Software Bills of Materials (SBOMs), and how to create them.

  • QNX Medical Device Bootscreen

    Creating a Medical Device Bootscreen for QNX

    QNX Medical Device Bootscreen tips for the popular micro-kernel OS designed for embedded systems and safety critical hardware.

  • FDA Guidance on Medical Device Cybersecurity Accessibility Alt description: FDA sign in front of FDA building that says "U.S. Department of. health and Human Services Food and Drug Administration"

    FDA Guidance on Medical Device Cybersecurity Overview

    2024 FDA guidance on medical device cybersecurity covering risk management, design controls and software validation is explained in this article. Cybersecurity, Risk Management, Secure Product Development Framework (SPDF) are also covered.

  • Medical Devices Developing Class C Firmware

    Developing Class C Firmware for Medical Devices

    How to develop Class C Firmware for medical devices and implement Segregation in compliance with the IEC 62304 Standard.

  • Using AI In Medical Devices

    Using Language Models (AI) In Medical Devices Responsibly

    Risks, potential roles, and tips for using Large Language Models (LLM) or (AI) in medical devices effectively and responsibly. Role of AI in medical devices: In the medical field, generative language models, colloquially known as “AI” or “LLM” must be used responsibly to enhance the skills of clinicians or improve patient experience without exposing either to increased risk.

  • Medical Device Design for Testability

    Medical Device Design for Testability

    Medical Device Design for Testability during development explores the pros and cons of its application throughout the entire design process design concern throughout the whole design process, ensuring that all parts of the product can be both manipulated and monitored allowing for thorough testing.

  • biomedical product development

    3 “P’s” of Biomedical Product Development Pitfalls

    Three common elements can be observed in biomedical product development projects that are doomed to failure. They are the Three “P’s” – Platform, Point of Care, and Program Manager.

  • Similarities and Differences between Medical Device 510(k) and CE Marking

    Understanding similarities and differences between Medical Device 510(k) and CE Marking regulatory pathways helps harmonize overall regulatory strategy.