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Focus on growing your business with ÌìÃÀ´«Ã½’s turn-key invasive and non-invasive physiological monitoring studies of medical devices and wearables. Our complete clinical validation solutions apply to the entire product lifecycle, from R&D to validation for regulatory submission. Partner with ÌìÃÀ´«Ã½ to decrease time to market, delivering products to patients and consumers when they need them.

For more than three decades, Element has served as the premier clinical testing and regulatory validation partner to the medical device, wearables, and consumer electronic industries. We have extensive experience in pulse oximetry, blood pressure (discrete and continuous), temperature monitoring, respiratory rate, ECG, heart rate variability, sleep studies, cardiac output, EtCO₂, hemodynamic monitoring, and many other physiological monitoring modalities. With medical technology moving toward in home monitoring, we also offer human factors testing, including formative and summative validation.

Expertly managed clinical validations

When you partner with ÌìÃÀ´«Ã½, no part of your study will be contracted out. We handle it all - protocol design, IRB submission and management, subject recruitment and payment, study performance, data analysis and, for validation studies, high-quality data packages ready for regulatory submission. Our substantial expertise in the physiological monitoring space, in addition to our fully equipped labs and network of associate hospitals, allows us to deliver best-in-class, complete solutions. Ready to start the conversation? Get in touch with us today.

Unparalleled regulatory and medical expertise

Successfully navigate complex regulations for devices, wearables, and electronics. Our regulatory experts will serve as an extension of your team, supporting and guiding you from the development of protocols to regulatory ready reports, as well as in discussions with regulatory bodies. ÌìÃÀ´«Ã½’s recognized and published industry leaders are among the primary authors of multiple monitoring equipment guidance documents and test specifications.

From study design to execution, we involve our staff anesthesiologists, pulmonologist, and cardiologists. Along with laboratories located on the Avista Hospital Medical campus near Denver, Colorado, and our vast network includes additional medical centers and hospital research partners. To know more, contact us today.

Optimize and adjust algorithms throughout R&D

Engineers can optimize and adjust algorithms based on real time data when physiological monitoring is conducted throughout R&D. While simulations provide a strong foundation for building algorithms, they cannot account for real-world interaction. Services are tailored to your needs and development stage, and consultative experts assist with data interpretation, helping you understand the variability in readings.

The ÌìÃÀ´«Ã½ advantage

Bring an optimal device to market quicker with industry-leading clinical validation services. Our consultative engineers, scientists, and clinicians act as an extension of your team, generating invaluable physiological and human factor data to inform product optimization. Successfully navigate complex regulations and discussions with regulatory bodies with ÌìÃÀ´«Ã½ by your side.

To learn more about clinical validation testing of wearables and medical devices, get in touch with us today.