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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  • Heart Valve Computational Simulation

    Heart valve simulation shifts the treatment paradigm

    Simulation technologies are revolutionizing the field of heart valve repair and replacement, offering unprecedented insights and capabilities. Enhancing our understanding of valve mechanics, improving device design, optimizing surgical techniques, and enabling personalized treatments, simulations are paving the way for better cardiovascular care and patient outcomes. This article explores the transformative role of heart valve computational simulation in understanding, and treating heart valve diseases.

  • 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)”.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.