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  The EU Breakthrough Device (BtX) Designation Program

  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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  ISO 14644-5:2025 Cleanroom Operations Explained

  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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  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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  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 Labeling Requirements: Compliance and Best Practices

  We all know medical devices have labels, but how often do we consider their purpose and the effort required to ensure they provide the right information? Device labelling serves as the interface between the manufacturer, the user, and regulatory bodies. (Note that being from Canada, we spell labelling with two Ls.)

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  Medical Device Sterilization Methods and EtO

  Sterilization is a critical process in the medical device industry as it provides a reliable way to ensure that devices are free from harmful microorganisms when they are used on patients. This blog talks about the categories of sterilization currently used on medical devices in manufacturing settings. It also addresses concerns surrounding the use of ethylene oxide (EtO), an indispensable method for sterilizing heat and moisture sensitive devices.

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  FDA Final Guidance on Remanufacturing of Medical Devices: Key Takeaways and Implications

  In May 2024, the FDA released an updated guidance document to help manufacturers, third-party service providers, and healthcare facilities determine whether their modifications fall under the category of remanufacturing. This guidance enables these entities to continue ensuring patient safety, regulatory compliance, and the effectiveness of remanufactured medical devices.

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  Common Mistakes for Medical Device Projects

  Common mistakes in medical device projects can create roadblocks that, if left unchecked, can snowball into costly setbacks.

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  FDA Draft Guidance on Chemical Analysis for Biocompatibility Assessment of Medical Device

  This blog explores key highlights of the Chemical Analysis for Biocompatibility Assessment of Medical Devices draft guidance, focusing on its scope, testing methodologies, and recommendations for reporting. In September 2024, the U.S. Food and Drug Administration (FDA) issued a draft guidance titled Chemical Analysis for Biocompatibility Assessment of Medical Devices.

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