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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  • 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.

  • Elearning LMS Medical Device

    How eLearning and LMS Empower Medical Device Employees

    elearning and LMS improve an employee’s ability to learn and adhere to the company QMS for medical device design and development.

  • 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)”.

  • 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.

  • 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.