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  FDA Draft Guidance on Chemical Analysis for Biocompatibility Assessment of Medical Device

  This blog explores key highlights of the Chemical Analysis for Biocompatibility Assessment of Medical Devices draft guidance, focusing on its scope, testing methodologies, and recommendations for reporting. In September 2024, the U.S. Food and Drug Administration (FDA) issued a draft guidance titled Chemical Analysis for Biocompatibility Assessment of Medical Devices.

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  2025 Medical Device Resolutions Round-Up

  Medical Device Commercialization Resolutions include Improved communications, aligning goals, using new tools, going paperless

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  2024 Top Medical Device Videos

  2024 Top Medical Device Videos features a round up of most viewed medical device videos from StarFish Medical includes a mix of new videos released in 2024 along with evergreen videos sharing medical device expertise. 

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  5 Regulatory Considerations For Developing a Combination Device

  A combination product is a product which comprises of two or more items which are covered by different regulations, for example a pharmaceutical and a medical device. As they are covered by two different regulatory structures, then more care needs to be taken when determining the regulatory strategy as it will be more complex.

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  Combination Product Regulation Basics

  What is a combination product and why is this important from a regulatory perspective? The simple answer is that a combination product is a product which comprises of two or more items which are covered by different regulations, for example a pharmaceutical and a medical device.

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