Focus on growing your business with Element’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 Element 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 Element, 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.
Clinical validation testing of medical devices and wearables
Pulse Oximetry Validation – Under highly controlled conditions, a test pulse oximeter will be evaluated for SpO2 accuracy performance over the specified range of oxygen saturation. At the same time, comparisons are made to arterial blood samples assessed by CO-Oximetry.
Blood Pressure Monitor Clinical Validation – Invasive arterial and non-invasive blood pressure testing follows the requirements of the current version of ISO 81060-2 and IEEE 1708, as well as the FDA consensus standard for blood pressure to the extent of recognition.
Respiratory Rate Monitor Validation Testing – Respiratory rate accuracy performance of the test monitor is evaluated in highly controlled conditions over a range of respiratory rates in specific demographics. Our participant database reflects various comorbidities including COPD and asthma as well as healthy individuals.
Temperature Monitoring Device Clinical Validation – Establish and execute a clear study plan for temperature monitor device validation testing. Our consultative experts serve as an extension of your team, working alongside you and the FDA.
Heart Rate Monitor Device Validation – Meet regulatory requirements for accuracy testing of heart rate monitoring devices. Element offers both FDA-cleared ECG simulator and FDA-cleared ECG monitor human validation testing.
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. Element’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 Element 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 Element by your side.
To learn more about clinical validation testing of wearables and medical devices, get in touch with us today.
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.
Medical Device Battery Testing
Element provides safety and certification testing for rechargeable lithium-ion and nickel metal hydride batteries used in hospital and home health applications.
EMI & EMC Testing
Element performs electromagnetic compatibility (EMC) and electromagnetic interference (EMI) testing for a variety of medical devices and components, including implantable devices, diagnostic tools and therapeutic equipment.
Medical Device Regulatory Services
Our medical device regulatory experts help manufacturers of medical devices with product registrations, quality management systems, and in-country and global approvals.