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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In this episode of Bio Break, Joris van der Heijden and Nick Allan dive into the FDA’s new regulations surrounding Laboratory Developed Tests (LDTs) and their impact on the medical device industry. As LDTs grow in complexity, including applications like genetic testing and AI-driven diagnostics, these regulatory changes mark a significant shift for laboratories, developers, and healthcare providers.
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In this episode of Bio Break, Joris van der Heijden and Nick Allan discuss the critical role of specialized facilities in the successful development of medical devices. From testing laboratories to clean rooms, they explore the infrastructure needed to support innovation and ensure safe, effective products reach the market.
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Whether you’re in the early stages of a new project or refining a product concept, this episode of Bio Break delves into the foundational importance of a well-defined Target Product Profile (TPP) in medical device development. It’s packed with practical advice and expert insights to set you on the path to success.
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In this episode of Bio Break, StarFish Medical experts Joris and Nick explore the groundbreaking FDA clearance of the first over-the-counter continuous blood glucose monitoring system. This exciting development marks a significant milestone in the world of diagnostics and opens new possibilities for patient-centered healthcare.