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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ASTM D4169 is a standard test method for performance testing of shipping containers and packaging systems. It evaluates the ability of shipping units to withstand the expected distribution environment. FDA recognizes it as a consensus standard as part of sterility testing that is commonly applied to all sorts of medical devices.
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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.
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This blog explores key highlights of the Chemical Analysis for Biocompatibility Assessment of Medical Devices draft guidance, focusing on its scope, testing methodologies, and recommendations for reporting. In September 2024, the U.S. Food and Drug Administration (FDA) issued a draft guidance titled Chemical Analysis for Biocompatibility Assessment of Medical Devices.
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Medical Device Commercialization Resolutions include Improved communications, aligning goals, using new tools, going paperless
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2024 Medtech Entrepreneur Webinars feature both standard expertise webinars and livecast recordings from Playbook events in Vancouver, Canada and Newport Beach, California.
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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.
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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.
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A combination product is a product which comprises of two or more items which are covered by different regulations, for example a pharmaceutical and a medical device. As they are covered by two different regulatory structures, then more care needs to be taken when determining the regulatory strategy as it will be more complex.
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What is a combination product and why is this important from a regulatory perspective? The simple answer is that a combination product is a product which comprises of two or more items which are covered by different regulations, for example a pharmaceutical and a medical device.