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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  • Health care, medicine, people eyesight and technology concept

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

  • 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.

    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

    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.

    The U.S. Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) have released a draft guidance document, Considerations for Including Tissue Biopsies in Clinical Trials, issued in January 2025.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.

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

  • ASTM D4169 Options packaging plant line and signal.

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

  • What are the most important medical device success factors during development and manufacturing? StarFish employees from QA/RA, NPI, Optics, Computational Analysis, Project Management and Manufacturing answer that question with the factors they deem most important for their area of expertise.

  • This blog explores key highlights of the Chemical Analysis for Biocompatibility Assessment of Medical Devices draft guidance, focusing on its scope, testing methodologies, and recommendations for reporting. In September 2024, the U.S. Food and Drug Administration (FDA) issued a draft guidance titled Chemical Analysis for Biocompatibility Assessment of Medical Devices.