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Key Trends Shaping the Future of Medical Device Testing and Certification

Explore the latest insights from UL Solutions expert Pamela Gwynn on the trends influencing how medical device manufacturers approach testing and certification requirements for market access.

Close up a nurse using a mobile device to scan a patient's CGM

Pamela Gwynn, principal engineer at UL Solutions, shares expert insights into the forces reshaping the medical device industry, including artificial intelligence (AI), cybersecurity, sustainability and regulatory harmonization.

“We will see more and more devices in what is currently considered the consumer wellness market become the devices used by the medical industry to monitor and treat patients.”
  • Pamela Gwynn, principal engineer, UL Solutions

Key takeaways

  • How smartwatches and wellness devices are becoming regulated medical tools
  • What home healthcare and telemedicine mean for usability testing
  • How AI is transforming diagnostics and rehabilitation
  • Why cybersecurity must be integrated early in device development
  • How sustainability and circular economy principles are influencing design
  • What IEC 60601-1-2 Ed. 4.1 means for electromagnetic compatibility
  • How global regulations like the EU AI Act and FDA ASCA are evolving

Gain the insights you need to confidently step into this new era of innovation and oversight.

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