Sleep Monitoring Device Validation
Get your sleep monitoring device validated through comprehensive testing that expedites regulatory approval and market launch. Element’s end-to-end service provided access to certified support at every stage. From development data to submission-ready reports, our sleep device testing delivers tailored results with speed and technical expertise.
What is Sleep Monitoring Device Validation at Element?
Sleep monitoring device validation tests the safety of devices used in sleep studies to diagnose common sleep disorders including sleep apnea, insomnia, and narcolepsy. At Element, we conduct overnight sleep studies in lab settings, measuring multiple physiological parameters with participants fitted with various monitors.
What Can Element Offer You For Sleep Monitoring Device Validation?
Products we test
Products we test
At Element, we validate all critical monitoring parameters for sleep disorder diagnosis including blood oxygen levels, respiratory rate, heart rate, eye movement, body movement, and brain activity. Our testing validates your device's ability to accurately measure and record these essential parameters throughout the sleep study duration.
Key tests offered
Key tests offered
We validate devices across essential sleep monitoring parameters during overnight studies. Our comprehensive testing covers blood oxygen, respiratory rate, heart rate, eye movement, body movement, and brain activity measurements. Each study provides 4-6 hours of continuous sleep data collection in controlled laboratory conditions.
Methods and solutions offered
Methods and solutions offered
Customized Participant Recruitment:
Element recruits participants based on the product’s intended claims. For devices diagnosing sleep apnea, we test both individuals with and without the condition, leveraging our extensive database of several thousand participants.
Controlled Sleep Study Setup:
Participants are monitored overnight in a controlled lab setting, wearing various devices to collect 4-6 hours of continuous sleep data.
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.
Expert Analysis and Reporting:
Once data is collected, Element’s certified sleep medicine physicians analyze it and provide a final report ready for regulatory submission. For development studies, only raw data is provided to the sponsor.
Which labs offer this service
Which labs offer this service
Element Boulder specializes in clinical validation testing for medical devices and wearables. For more than three decades, we have proudly served as the premier clinical testing and regulatory validation partner to the medical device, wearables and consumer electronic industries.
Wraparound support services
Wraparound support services
We provide comprehensive support throughout your device development journey, including human factors and usability testing alongside validation studies. Our single-supplier approach means you get complete testing coverage from one partner. For development purposes, we can focus solely on providing the data you need to optimize your device's performance and functionality.
Standards we test to and products we test
- 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
- Sleep apnea monitoring devices
- Sleep wearables
- Sleep diagnostic equipment
- Sleep monitoring devices
Your Challenges, Our Solutions
Complete regulatory documentation
Expert participant matching
Certified medical analysis
Flexible development support
Why Choose Element
Complete testing solution
Qualified participant access
Certified medical expertise
Flexible testing options
4-6+hours
2Key medical device
1,000+Test participants
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