It’s not always easy to decipher the study parameters and requirements for blood pressure monitoring clinical validation testing. That’s where Element comes in. We simplify the process with turnkey solutions for invasive arterial and non-invasive blood pressure testing, from drafting protocols to guiding you in setting up a successful study for regulatory submission.
Blood pressure is one of the critical vital signs of life, and blood pressure monitoring devices provide a noninvasive method for the assessment of blood pressure. Blood pressure monitors are used routinely in a wide variety of medical applications, from physicals to surgery, to help physicians diagnose and treat blood pressure. In addition to being widely used in the healthcare industry, these sensors are becoming routinely integrated into wearable technology like smart watches and smart devices.
BP monitor clinical validation testing overview
Regulatory standards require that accuracy of blood pressure devices be tested in humans; simulators may not be used to evaluate accuracy in blood pressure devices. We provide both invasive arterial and non-invasive blood pressure testing that can be utilized for focused development tests and FDA and other regulatory agency submissions.
Your entire blood pressure monitoring device clinical validation study will be conducted by Element. Our experienced team will take care of protocol design, IRB submission and management, recruitment and payment of participants, study performance, analysis of data, and assembling high-quality data packages ready for regulatory submission. Connect with an expert to explore a partnership.
How blood pressure monitor clinical validation studies are conducted
Blood pressure accuracy performance of the test monitor is evaluated in highly controlled conditions over a range of blood pressures in specific demographics. Our participant database reflects all confounding conditions including hypertension and hypotension as well as normal blood pressures, and includes a range of pigmentation, body mass, and age. For both non-invasive and invasive types of data collection, we follow 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.
Regulatory bodies require testing of the monitor’s ability to track a change in blood pressure for certain types of blood pressure devices. Element’s proprietary methods of inducing blood pressure change allow for straightforward collection of this data in a variety of participants.
For invasive data collection, arterial blood pressure waveforms and digital blood pressures are collected at a frequency of 100Hz. These waveforms and raw data are provided upon request in addition to other engineering data as part of the development process or final report.
For noninvasive data collection (dual auscultation), data is compared to our proprietary NIST-traceable digital reference sphygmomanometers. These reference sphygmomanometers remove many of the inaccuracies involved with the typical use of standard mercury manometers, providing a more accurate reference measurement. Want to know more? Get in touch with our team today.
BP monitoring device validation study data formatted for regulatory agencies
We understand that the study parameters and requirements are not always easy to decipher. Our staff are members of the ISO and IEEE blood pressure committees and are actively involved in the development of current standards. With our participation in drafting your protocols, the process is simplified, and experienced consultants can guide you in setting up a successful study for FDA and other regulatory submissions.
The Element advantage
Our recognized and published industry leaders are among the primary authors of multiple monitoring equipment guidance documents and test specifications, including Hersh, Lawrence T. et al. “Validation of a conical cuff on the forearm for estimating radial artery blood pressure.” Blood Pressure Monitoring 19 (2014): 38–45.
The medical device, wearables, and consumer electronic industries have partnered with Element for more than three decades for clinical testing and regulatory validation. Our substantial expertise in the physiological monitoring space, in addition to fully equipped labs and network of associate hospitals, allows us to continually deliver best-in-class, complete solutions.
- ISO 81060-2: Non-invasive sphygmomanometers — Part 2: Clinical investigation of intermittent automated measurement type
- IEEE 1708: Standard for Wearable Cuffless Blood Pressure Measuring Devices
- FDA Guidance Document - Non-Invasive Blood Pressure (NIBP) Monitor Guidance
- FDA Guidance Document - Non-Automated Sphygmomanometer (Blood Pressure Cuff) Guidance - Version 1 - Guidance for Industry
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