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.

THE CONTENT OF THIS WEBINAR IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT INTENDED TO CONVEY LEGAL OR OTHER PROFESSIONAL ADVICE.

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.