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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Nigel Syrotuck breaks down the realistic medical device V&V cost and schedule for terminally sterilized devices, picking up after design freeze and walking through each major phase of the process.
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Graphical mind maps created in online whiteboards offer a low-barrier, highly collaborative approach to early risk analysis in medical device development.
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This medical vs wellness example shows how device classification can directly change functionality. Even when hardware is similar, what the device is allowed to do can be very different.
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Ariana Wilson and Mark Drlik explore how bias can enter the development process and why engineers and manufacturers must actively work to prevent it.
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The FDA agentic AI is making headlines after the agency announced its own internal AI review tool. In this episode of MedDevice by Design, Ariana and Mark discuss what this could mean for medical device submissions and regulatory efficiency.
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For manufacturers of novel devices that can make a significant impact to patient health, the goal of the program is to offer a path to streamlined and potentially faster market entry without sacrificing the rigour around ensuring safety and performance.
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When I was starting out in medical devices, the discussion focused on the possibility of an internet of things and the promise of “big data” about everything.
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With the release of ISO 14644-5:2025, Cleanrooms and associated controlled environments, Part 5: Operations, the standard places increased emphasis on operational discipline, human factors, and contamination control behaviour.
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This article outlines the core elements of the PCCP framework, the types of modifications it applies to, and how the FDA expects manufacturers to use it in practice.
