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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Medical device design transfer is a critical phase in the development process, marking the transitory phase from the design and development stage to manufacturing. This phase ensures that the medical device continues to meet its safety, effectiveness, and regulatory compliance once production begins. It is the final phase in the development process and sometimes overlooks or underestimates the amount of time and effort required to ensure that final manufactured devices meet requirements.
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Systems-thinking must always be present in medical device development. Systems Engineers (SEs) live where complex development needs managing. In a very small project team people can communicate continuously and tightly enough that everybody understands where they're headed and what's going on.
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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 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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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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In this episode of Bio Break, StarFish Medical experts Joris and Nick dive into the transformative concept of Continuous Analyte Monitoring (CxM) and its growing role in wearable medical devices. They discuss the value of tracking metabolic markers over time, as opposed to relying on static time-point measurements, and how this approach enhances precision in both diagnostics and treatment.
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Predetermined Change Control Plans (PCCPs) Draft Guidance with Implications for Medical Device Manufacturers and regulatory framework
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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.