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  Difference Between Class 1, 2, and 3 Medical Devices

  Understanding medical device classifications is critical for compliance, risk management, and time-to-market success. Whether you’re designing a wearable sensor or a life-sustaining implant, knowing how your device fits into FDA Class 1, 2, or 3 categories is essential.

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  Drug Delivery Strategy Guide

  This in-depth drug delivery strategy guide from StarFish Medical explores how to design, develop, and deliver breakthrough drug-device combination products.

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  AI for Hardware Design in Medical Devices

  AI is quietly reshaping how hardware teams work. At StarFish, it’s become a versatile collaborator across the product lifecycle from early sketches to prototype validation.

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  FDA Regulatory Books and PCR Memoirs: End-of-Summer Picks with Nick and Nigel

  Nick Allan and Nigel Syrotuck share their end-of-summer reading list, featuring FDA regulatory books and PCR memoirs. From navigating regulatory hurdles to celebrating groundbreaking discoveries, their choices show how science reading can be both educational and entertaining.

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  Look Before You Build: The Role of the MAUDE Database in Medical Device Development

  Medical device development is a complex process that requires careful attention at every stage.

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  Understanding Contrast Agents in Imaging

  Nigel and Nick explore how contrast agents in imaging support medical device trials and diagnostics. While bones appear clearly in standard X-rays, soft tissues like those in the nasal cavity often require contrast agents to become visible.

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  Medical Device Drop Testing in Action

  Medical device drop testing helps ensure that products and packaging survive real-world handling. We demonstrate in-house drop testing on an actual device and its packaging using a custom-built drop tester.

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  Test Method Validation in Medical Device Development

  In the highly regulated world of medical device development, ensuring product safety, quality, and compliance is essential. One critical yet often overlooked aspect of this process is test method validation (TMV) in medical device development.

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  Medical Device Sterilization Methods Explained

  Ariana and Mark walk through FDA-approved options and explain how to select the right one for your product. From metals to plastics and electronics, not all devices can handle the same process.

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