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 use of AI in medical device review - A computer chip labeled "AI" on the left side is connected by a black arrow pointing to the right, where wooden blocks stacked vertically spell out "FDA." Above the image is a bold caption that says "They're doing it!" in white text on a black background. The image suggests the FDA is adopting AI technology.

    How the FDA Is Using AI in Regulatory Review

    Ariana Wilson and Mark Drlik dive into how the FDA is adopting artificial intelligence to modernize its regulatory processes. With a new chief AI officer in place and rumors of collaboration with OpenAI, the agency is taking major steps to automate review workflows and improve efficiency.

  • Health care, medicine, people eyesight and technology concept

    Making an Ophthalmic Instrument Safety Assessment

    Optics Physicist and Engineer share approaches to performing pre-screen Ophthalmic Instrument Safety Assessment testing in-house.

  • Purple text reads 'FDA rejects Lab Results?' next to a rubber stamp marked 'REJECTED' resting on a document.

    When FDA Trust Is Broken: Lessons from the MedLink Scandal

    In this episode of MedDevice by Design, Ariana Wilson and Mark Drlik examine what happened, what it means for medical device innovators, and how the FDA’s ASCA (Accreditation Scheme for Conformity Assessment) program helps reduce regulatory risk.

  • White and colored label rolls isolated on white background with shadow reflection. Color reels of labels for printers. Labels for direct thermal or thermal transfer printing. Abstract background.

    Medical Device Labeling Requirements: Compliance and Best Practices

    We all know medical devices have labels, but how often do we consider their purpose and the effort required to ensure they provide the right information? Device labelling serves as the interface between the manufacturer, the user, and regulatory bodies. (Note that being from Canada, we spell labelling with two Ls.)

  • Room for sterilization of medical instruments in a modern outpatient clinic

    Medical Device Sterilization Methods and EtO

    Sterilization is a critical process in the medical device industry as it provides a reliable way to ensure that devices are free from harmful microorganisms when they are used on patients. This blog talks about the categories of sterilization currently used on medical devices in manufacturing settings. It also addresses concerns surrounding the use of ethylene oxide (EtO), an indispensable method for sterilizing heat and moisture sensitive devices.

  • Mammalogist doctor examines a woman breasts and lymph nodes during appointment. Skillful oncologist puncture of mammary glands of young patient under review ultrasound for diagnosis of breast cancer.

    Considerations for Including Tissue Biopsies in Clinical Trials

    The U.S. Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) have released a draft guidance document, Considerations for Including Tissue Biopsies in Clinical Trials, issued in January 2025. It provides recommendations for sponsors, investigators, institutions, and Institutional Review Boards (IRBs) on the safe and ethical incorporation of tissue biopsies in clinical trials.

  • A person adjusting a medical device in a clinical setting.

    FDA Final Guidance on Remanufacturing of Medical Devices: Key Takeaways and Implications

    In May 2024, the FDA released an updated guidance document to help manufacturers, third-party service providers, and healthcare facilities determine whether their modifications fall under the category of remanufacturing. This guidance enables these entities to continue ensuring patient safety, regulatory compliance, and the effectiveness of remanufactured medical devices.

  • Common Mistakes for Medical Device Projects A businessman wearing a blue suit and an orange tie is pointing at a transparent virtual interface with hexagonal icons. The central hexagon displays the words "REGULATORY COMPLIANCE." Surrounding it are four smaller hexagons with white icons, including a scale inside a gear (symbolizing legal and ethical standards), a stack of binders (representing documentation), a checklist (indicating compliance requirements), and a person next to a legal symbol (denoting regulatory oversight). The background is blurred with a brick wall visible.

    Common Mistakes for Medical Device Projects

    Common mistakes in medical device projects can create roadblocks that, if left unchecked, can snowball into costly setbacks.

  • ASTM D4169 Options packaging plant line and signal.

    Clarifying ASTM D4169 Options – It’s all in the details

    ASTM D4169 Options for this standard test method of performance testing shipping containers and packaging systems are explored.