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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Reliability testing is an effective money saving NPI tool that helps produce high-quality medical devices which work consistently.
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The Bleeding Edge explains how 510K cleared medical devices are clinically proven to improve patient outcomes and save lives.
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The book Bad Blood eloquently demonstrates the importance of properly developing medical devices under ISO 13485.
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Proper documentation is an up-front investment of time and effort that pays big dividends later in medical device development.
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6 benefits mean the FDA program for breakthrough medical devices may be your best regulatory option for novel medical devices.
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FDA's Early Feasibility Studies Program (EFS) is a great option in early stage development looking to advance your program by gathering data.
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Proper research and communication with authorities in each country of interest will make Medical Device International Regulations smoother to navigate.
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ISO/IEC 17025:2017 includes many changes. Three points to keep in mind: more options, involvement of risk, updates in current technology.
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FDA Guidance on Additive Manufacturing (AM) – offers new ways to integrate parts not only for prototypes, but for final products.
