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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  • Root Cause Analysis

    Root Cause Analysis for Medical Device Development

    Overview of tools for Root Cause Analysis is an important tool in medical device development and manufacturing.

  • Close-up of gloved hands holding a blue laboratory microtube rack with small clear sample tubes. The background shows a blurred laboratory setting, suggesting a scientific environment. Overlaid text reads 'Beyond Blood: NEW Testing Methods' in bold purple and gray font, highlighting the theme of alternative diagnostic sampling techniques.

    Bio Break: Exploring Alternative Bodily Fluids for Diagnostics

    In this episode of Bio Break, StarFish Medical experts Joris and Nick tackle an intriguing question: can alternative bodily fluids like sweat, saliva, or urine offer viable alternatives to blood sampling for medical diagnostics? While blood remains the gold standard for clinical testing, advancements in non-invasive sampling methods are opening new possibilities, particularly in wearable devices and at-home diagnostics.

  • Predetermined Change Control Plans Accessibility Alt description: FDA sign in front of FDA building that says "U.S. Department of. health and Human Services Food and Drug Administration"

    5 Key Features of FDA Draft Guidance for Predetermined Change Control Plans (PCCPs) for Medical Devices

    Predetermined Change Control Plans (PCCPs) Draft Guidance with Implications for Medical Device Manufacturers and regulatory framework

  • continuous integration medical device Circuit Board

    How Continuous Integration Improves Medical Device Firmware

    Continuous Integration (CI) firmware will help medical device software developers show regulators that their code is of high quality.

  • A serene forest illuminated by numerous glowing fireflies, symbolizing the inspiration nature provides for innovations in medical diagnostics. Text overlaid on the image reads: "Nature-inspired Diagnostics" in bold purple and white fonts.

    Bio Break: How Nature-Inspired Biosensors Are Revolutionizing Medical Devices

    In this episode of Bio Break, Nick and Joris dive into the fascinating realm of biosensors, showcasing how nature’s biological processes inspire groundbreaking innovations in medical device technology. From jellyfish to fireflies, the natural world has provided invaluable tools that are transforming diagnostics and research.

  • A glowing AI chip embedded within a futuristic black and gold circuit board, symbolizing advanced artificial intelligence and technological innovation.

    A Practical Future of Developing AI for Medical Devices

    Artificial intelligence (AI) has rapidly become a transformative force across industries, but its application in medical devices presents unique challenges. In his article "A Practical Future of Developing AI for Medical Devices" for MD+DI, Thor Tronrud, a Research and Data Analysis-Focused Software Engineer at StarFish Medical, sheds light on bridging knowledge gaps, navigating regulatory constraints, and developing robust AI solutions for medical devices.

  • Multiple computer monitors displaying financial and data analytics charts, graphs, and numerical data in a high-tech setup, indicating real-time monitoring and analysis in a professional workspace.

    Understanding Human Errors in Medical Device Root Cause Analysis

    Root Cause Analysis (RCA) is a cornerstone process for identifying and resolving nonconformities in the medical device industry. Yet, a critical aspect often overlooked is the role of human error. In her online-exclusive article "Understanding Human Errors in Medical Device Root Cause Analysis" for Medical Product Outsourcing (MPO), StarFish Medical's Vinky Kohli examines how integrating human factors into RCA can lead to safer devices and improved processes.

  • A healthcare professional wearing a surgical mask and scrubs holds a clipboard with a checklist partially completed. The text overlay reads "Clinical Trials: Expert Insights" in bold purple and gray lettering, emphasizing expertise and precision in clinical trial processes. The image suggests a focus on medical research and the methodology behind clinical studies.

    Bio Break: Understanding Clinical Trials – Key Steps and Expert Insights

    In this engaging episode of Bio Break, Nick and Joris dive into the complexities of clinical trials as a critical component of medical product development. Whether you're a developer embarking on your first trial or a seasoned professional seeking guidance, this discussion provides actionable insights and resources to streamline the process.

  • FDA Laboratory Developed Tests Policy

    Impact of FDA Laboratory Developed Tests Policy

    The U.S. Food and Drug Administration (FDA) made a significant update to its regulatory approach for in vitro diagnostic products (IVDs), including laboratory developed tests (LDTs). Detailed in a FDA Laboratory Developed Tests Policy guidance document issued on June 25, 2024.