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The Design Process of Medical Devices at DeviceLab | Part 4


Part 4: The 6 Development Tracks – Design in Parallel Medical device development is an interdisciplinary task. Designers, engineers, scientists, manufacturing, regulatory, medical, legal, and business specialists all work together toward a common goal but have distinct contributions to medical device development. At DeviceLab, we’ve organized these efforts into six tracks, which cover the needs […]

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The Design Process of Medical Devices at DeviceLab | Part 3


Part 3: The FDA “Waterfall” and DeviceLab’s 6 Phases You’ve all seen it. It’s one of the first slides in the Design Controls training class deck: It’s a description of the interactions between certain factors and processes in the development of medical devices. In the white boxes are a series of steps from User Needs […]

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The Design Process of Medical Devices at DeviceLab | Part 2


The 6 Phases of a Medical Device Development Project In the second part of this series, we explore the temporal aspect of projects. What follows is a description of how DeviceLab organizes the sequence of events in a project into distinct phases.  We typically employ six phases for every project. Sometimes we participate in all […]

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