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  Medical vs Wellness Device Example

  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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  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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  Data Management Is Now a Core Device Requirement

  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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  Medical vs Wellness Devices: What Really Makes the Difference?

  Ariana Wilson and Mark Drlik break down medical vs wellness devices and explain why two products with identical hardware can fall into completely different regulatory categories.

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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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  When FDA Trust Is Broken: Lessons from the MedLink Scandal

  In this episode of MedDevice by Design, Ariana Wilson and Mark Drlik examine what happened, what it means for medical device innovators, and how the FDA’s ASCA (Accreditation Scheme for Conformity Assessment) program helps reduce regulatory risk.

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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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  Considerations for Including Tissue Biopsies in Clinical Trials

  The U.S. Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) have released a draft guidance document, Considerations for Including Tissue Biopsies in Clinical Trials, issued in January 2025. It provides recommendations for sponsors, investigators, institutions, and Institutional Review Boards (IRBs) on the safe and ethical incorporation of tissue biopsies in clinical trials.

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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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