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The Difference Between a Medical and a Wellness Device

Our experts discuss the difference between a medical device and a wellness device. Discover the importance of a manufacturer’s claims about a product and how this can impact the classification.

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Watch now: The Difference Between a Medical and a Wellness Device

In this session, we discuss the difference between a medical device and a wellness device. We’ll explore the importance of the manufacturer’s claims about a product and how the claim can impact the classification.

Webinar date: July 14, 2022

Speaker: Paul Hilgeman, global director and industry leader for medical

 

Wellness device or medical device?

Watch the presentation to learn about:
  • Testing using standards.
    • Medical equipment 60601 series of standards.
    • Health and hygiene wearables.
    • Information technology wearables.
    • Certification.
  • Biocompatibility/toxicity.
  • Human factors/usability.
  • Testing to support claims.
    • Accuracy of measurement, number of steps, distance, laps.
    • Environmental claims.
    • Durability.
    • Custom.

 

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