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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  • Commercializing Medical Devices with Optics

    Commercializing Medical Devices with Optics

    Engineers, regulatory, manufacturing and optics experts share their experiences and lessons learned commercializing hundreds of medical devices with optics components and interacting with optics engineers.

  • Optical Coherence Tomography Types

    A Comparison of Detection and Imaging Methods Used in Optical Coherence Tomography

    Overview of Optical Coherence Tomography (OCT) Types includes some advantages and disadvantages of the imaging techniques in medical devices.

  • A smiling man with a beard and checkered shirt, sitting in front of a background with the text 'Don't miss this step' and an illustrated arrow pointing downwards.

    Bio Break: Target Product Profile

    Whether you’re in the early stages of a new project or refining a product concept, this episode of Bio Break delves into the foundational importance of a well-defined Target Product Profile (TPP) in medical device development. It’s packed with practical advice and expert insights to set you on the path to success.

  • 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.