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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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.
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In this episode of Bio Break, StarFish Medical experts Joris van der Heijden and Nick Allan celebrate Thanksgiving by sharing a heartwarming and hilarious family tradition: preparing the perfect turkey. Through this tale of generations working together to create the iconic holiday meal, they uncover a surprising lesson that applies to medical device development and procedural design.
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In the fast-paced world of medical device development, ensuring a smooth design transfer is critical for product success. However, a common pitfall arises when limits around essential performance are not well defined. In his recent article for Medical Product Outsourcing (MPO), Dana Trousil, StarFish Medical’s Mechanical Engineering Team Manager, dives into the challenges and solutions for addressing these issues.
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Continuous Integration (CI) firmware will help medical device software developers show regulators that their code is of high quality.
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In this episode of Bio Break, Joris van der Heijden and Nick Allan discuss an advanced category of combination devices: drug activation devices. Unlike drug delivery devices that transport medication to specific locations, drug activation devices ensure the drug becomes active precisely where it is needed in the body, reducing systemic side effects and enhancing therapeutic effectiveness.
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Artificial intelligence (AI) has rapidly become a transformative force across industries, but its application in medical devices presents unique challenges. In his article “A Practical Future of Developing AI for Medical Devices” for MD+DI, Thor Tronrud, a Research and Data Analysis-Focused Software Engineer at StarFish Medical, sheds light on bridging knowledge gaps, navigating regulatory constraints, and developing robust AI solutions for medical devices.
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Root Cause Analysis (RCA) is a cornerstone process for identifying and resolving nonconformities in the medical device industry. Yet, a critical aspect often overlooked is the role of human error. In her online-exclusive article “Understanding Human Errors in Medical Device Root Cause Analysis” for Medical Product Outsourcing (MPO), StarFish Medical’s Vinky Kohli examines how integrating human factors into RCA can lead to safer devices and improved processes.
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In this engaging episode of Bio Break, Nick and Joris dive into the complexities of clinical trials as a critical component of medical product development. Whether you’re a developer embarking on your first trial or a seasoned professional seeking guidance, this discussion provides actionable insights and resources to streamline the process.
