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  • FDA Draft Guidance on Chemical Analysis for Biocompatibility Assessment of Medical Device

    This blog explores key highlights of the Chemical Analysis for Biocompatibility Assessment of Medical Devices draft guidance, focusing on its scope, testing methodologies, and recommendations for reporting. In September 2024, the U.S. Food and Drug Administration (FDA) issued a draft guidance titled Chemical Analysis for Biocompatibility Assessment of Medical Devices.

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    5 Regulatory Considerations For Developing a Combination Device

    A combination product is a product which comprises of two or more items which are covered by different regulations, for example a pharmaceutical and a medical device. As they are covered by two different regulatory structures, then more care needs to be taken when determining the regulatory strategy as it will be more complex.

  • Cartridge and blue medicine inhaler in a room front view

    Combination Product Regulation Basics

    This blog discusses the combination product regulation basics and explains how these types of products are regulated in the US and EU.

  • 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.

  • Biocompatibility Evaluation ISO 10993-1 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 Biocompatibility Evaluation ISO 10993-1

    Review of FDA Guidance on Using ISO 10993-1 integrating biocompatibility evaluation within the risk management process, as outlined in the FDA Guidance Document  Use of International Standard ISO 10993-1, Biological Evaluation of Medical Devices Part 1: Evaluation and testing within a risk management process.

  • A close-up of a medical professional wearing blue gloves and a white lab coat, working with a combination medical device on a mannequin arm. The text overlay reads "Combination Devices in Clinical Trials: Bridging Two Worlds."

    Bio Break: Clinical Trials for Medical Devices vs. Pharmaceuticals

    In this episode of Bio Break, StarFish Medical experts Joris and Nick break down the key differences and similarities between clinical trials for medical devices and pharmaceutical products. As the conversation unfolds, they provide valuable insights into the distinct processes and challenges associated with these two types of trials, including the complexities of combination devices that bridge both worlds.

  • CM&S Medical Device Submissions 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 Computational Modeling and Simulation in Medical Device Submissions

    Summary of nine-step process for developing and assessing the credibility of CM&S for regulatory submissions in the FDA Guidance Document “Assessing the Credibility of Computational Modeling and Simulation (CM&S) in Medical Device Submissions (17th November 2023)”.

  • Laboratory Developed Tests vs. In Vitro Diagnostics Joris van der Heijden and Nick Allan dive into FDA’s new regulations. A scientist in a lab coat and purple gloves examines a specimen under a microscope, while another scientist works in the background in a laboratory setting. The text overlay reads "And now? New FDA LDT Ruling.

    Bio Break: Laboratory Developed Tests vs. In Vitro Diagnostics

    Laboratory Developed Tests vs. In Vitro Diagnostics Joris van der Heijden and Nick Allan dive into FDA’s new regulations.