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 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.

  • Starting Medical Device Project

    Starting Medical Device Projects on the Right Foot

    Four areas that can make or break a new medical device development project from the start. Experts identify actions and offer advice that helps ensure new medical device projects start on the right foot.

  • 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)”.

  • 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

    In this episode of Bio Break, Joris van der Heijden and Nick Allan dive into the FDA’s new regulations surrounding Laboratory Developed Tests (LDTs) and their impact on the medical device industry. As LDTs grow in complexity, including applications like genetic testing and AI-driven diagnostics, these regulatory changes mark a significant shift for laboratories, developers, and healthcare providers.

  • Medical Device Speed to Market

    14 Ways to Increase Medical Device Speed to Market

    Speed to market is a crucial part of medical device success. Experts draw upon their experience with hundreds of medical device products for proven tips and recommendations that increase medical device speed to market without sacrificing safety or quality.

  • Post-Market Surveillance Medical Devices

    Medical Device Post-Market Surveillance Enhances Safety

    Medical device post-market surveillance (PMS) is important to identify and address potential safety issues and improving device performance. Article covers regulatory landscape, challenges, innovations and collaborative efforts.

  • 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.

  • ESG Medical Device Impact

    ESG Medical Device Impact

    Environmental, Social and Governance (ESG) Medical Device Impact tips to ensure that your products fulfill compliance obligations. Major buyers request ESG reporting from suppliers as new and revised regulations require supply chain attention.

  • 2024 Regulatory Trends

    4 Regulatory Trends to Watch In 2024

    Overview of 2024 Regulatory trends include QMSR, LDTs, FDA guidances, and timelines in the EU for MDR and IVDR.