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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  • 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 Medical Device Cybersecurity

    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

    3 points of the IEC 62304 Standard specific to the design of Class C Medical Device Firmware are Segregation, Detailed Design for Interfaces, Additional Software Unit Acceptance Criteria. This article shares StarFish Medical development approach to Segregation.

  • 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.

  • Inclusion Women in STEM

    Inspiring Inclusion – Women in STEM

    Director of QA/RA shares statistics on women in STEM and inspiration she has gained from inclusion improvements during her career in this article celebrating

  • 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.