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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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  8 Client Traits That Maximize Your MedTech CDMO Partnership

  You have a great MedTech innovation idea and are trying to decide whether to build a team to commercialize a medical device…

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  How Shear Stress and Residence Time Simulations Shape Safer Biological Fluid Handling Devices

  The impact of shear stress is critical to effectively design medical devices that handle biological fluids such as proteins or cell culture media. For example, non-physiological shear stress (NPSS) on blood is a key factor because hemolysis (cell rupture) could occur due to accumulated stress.

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  How Computational Modeling and Simulation Accelerates Medical Device Innovation

  The costs of early-stage medical device development in North America and Europe continue to rise. Increasing technical complexity and the compounding costs of nonclinical and clinical evaluations are driving this trend.

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