Ensure the safety of devices used in sleep studies to diagnose common sleep disorders when you partner with Element for sleep monitoring device validation testing.
From obtaining data needed to optimize devices during development to preparing final reports ready for regulatory submission, Element’s comprehensive and sleep studies are tailored to meet your needs – and the needs of sleep monitoring devices and sleep wearables. Interested in sleep device testing and validation? Get in touch to learn more.
How sleep monitoring devices are tested for safety
Volunteer study participants are recruited by Element based on the intended claims of the product to be tested. For example, a device claiming to diagnose sleep apnea or other related conditions needs to be tested in individuals already confirmed to have this disorder, as well as individuals who have not had sleep studies in the past. Our database of participants includes several thousand individuals both with and without sleep apnea.
Participants are brought into a lab setting, fitted with a variety of monitors, and asked to sleep overnight with at least 4-6 hours of continuous sleep data.
Once the data has been collected, Element’s experts analyze the data and provide a final report ready for regulatory submission. Our physicians are certified in sleep medicine by the American Board of Sleep Medicine.
Alternatively, if the study is purely for development purposes, only data will be provided to the sponsor. So, let’s talk about your device and how our sleep device validation services can make a difference.
Why sleep monitoring device validation is important
Devices must be tested for safety before they can be used in a sleep study to diagnose relatively common sleep disorders including sleep apnea, insomnia, and narcolepsy. During a sleep study, patients are connected to a variety of monitors to measure indicators such as blood oxygen, respiratory rate, heart rate, eye movement, body movement, and brain activity. A board-certified physician will then evaluate the data, including sleep stages, and make a diagnosis. Need support testing your sleep monitoring device? Let’s talk.
The Element advantage
Demonstrate the safety of sleep monitoring devices when you partner with Element. Bring optimized devices to market with our wraparound services, including human factors and usability testing. Interested in knowing more about Element’s sleep monitoring device validation testing? Contact our experts today.
- ISO 80601-2-70:2020(en) Medical electrical equipment — Part 2-70: Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment
- American Academy of Sleep Medicine (AASM) Accreditation
As a comprehensive testing partner, you’ll enjoy the benefit of a single supplier source for all of your testing needs, from mechanical testing and environmental simulation to EMC and wireless device testing.
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