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.

Archive Filters
Actions
  • 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.

  • Biggest Medical Device Success Factors

    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.

  • FDA Draft Guidance on Chemical Analysis for Biocompatibility Assessment of Medical Device

    This blog explores key highlights of the Chemical Analysis for Biocompatibility Assessment of Medical Devices draft guidance, focusing on its scope, testing methodologies, and recommendations for reporting.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.

  • Medical Device Resolutions This image features a notepad with "2025" written boldly at the top, accompanied by a checklist containing three checked boxes. Nearby, there is a pair of eyeglasses, a cup of coffee, a pen, and a calculator, all arranged on a wooden table.

    2025 Medical Device Resolutions Round-Up

    Medical Device Commercialization Resolutions include Improved communications, aligning goals, using new tools, going paperless

  • Medtech Entrepreneur Webinars

    2024 Top Medtech Entrepreneur Webinars

    2024 Medtech Entrepreneur Webinars feature both standard expertise webinars and livecast recordings from Playbook events in Vancouver, Canada and Newport Beach, California.

  • Collage of photos that represent the top blogs from 2024.

    2024 Top Medical Device Blogs

    2024 Top Medical Device Blogs written in 2024 and the 10 most read evergreen blogs during 2024 include three new authors, two group blogs and five articles from blogging veterans.

  • Top Medical Device Videos

    2024 Top Medical Device Videos

    2024 Top Medical Device Videos features a round up of most viewed medical device videos from StarFish Medical includes a mix of new videos released in 2024 along with evergreen videos sharing medical device expertise.