Meet regulatory requirements for accuracy testing of heart rate monitoring devices. Element’s turnkey clinical validation solutions apply to the entire product lifecycle, from R&D to validation. Regulatory experts serve as an extension of your team, providing guidance and advisement throughout the regulatory process - including discussions with regulatory bodies.
Regulatory agencies require accuracy of heart rate monitoring devices be tested in humans. When the entire claimed range of heart rates can’t be achieved in a human study, they may be tested via heart rate simulators, such as an FDA-cleared ECG simulator and pulse oximetry simulator.
How heart rate monitor studies are conducted
Element offers clinical validation testing to both FDA-cleared ECG simulator and FDA-cleared ECG monitor human validation testing at our facilities. Let’s talk about your device and how we can help you meet regulatory requirements.
FDA-cleared ECG simulator heart rate monitor clinical validation
An FDA-cleared ECG simulator is used to measure heart rate over the entire claimed range, which is typically larger than can be collected in the clinical laboratory from humans. The data output for this type of testing is a numerical heart rate value.
Human clinical validation with FDA-cleared ECG monitor
The second approach is collection of data with an FDA-cleared ECG monitor from humans in the laboratory. Both sets of data - from simulator and humans - are analyzed for the final accuracy determination.
Using both simulator and human data provides regulatory bodies with a more complete picture, although it’s not required to utilize both types of data collection for regulatory submission. So, let's talk about your device and how Element's clinical validation testing can help you achieve regulatory approval.
The Element advantage
In addition to being widely used in the healthcare industry, heart rate monitoring sensors are becoming integrated into wearable technology, including smart watches and smart devices for personal use. Heart rate monitoring can be used to indicate the body’s response to illness and other conditions - for example, the body’s response to infection - and inform healthcare decisions. Heart rate is also one of the four vital signs measured and tracked at all wellness visits and continuously monitored during critical illnesses.
Leverage our expertise and decrease time to market - get your products to patients when they need them. For more than three decades, the medical device, wearables, and consumer electronic industries have partnered with Element for clinical testing and regulatory validation. Interested in in heart rate monitor validation? Start the conversation with our experts.
To learn more about Element’s clinical validation wrap-around services, including human factors testing, contact us today.
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