临床验证试验

Focus on growing your business with im体育APP’s turn-key invasive and non-invasive physiological monitoring studies of medical devices and 穿戴. Our complete 临床验证 solutions apply to the entire product lifecycle, from R&D进行监管提交的验证. Partner with im体育APP to decrease time to market, delivering products to patients and consumers when they need them.

三十多年了, im体育APP has served as the premier clinical testing and regulatory validation partner to the medical device, 穿戴, 以及消费电子im体育平台app下载. We have extensive experience in pulse oximetry, 血压(离散和连续), 温度监控, 呼吸速率, 心电图, 心率变异性, 睡眠研究, 心输出量, EtCO₂, hemodynamic monitoring, and many other physiological monitoring modalities. With medical technology moving toward in home monitoring, 我们还提供人为因素测试, 包括形成性和总结性验证.

熟练管理临床验证

When you partner with im体育APP, no part of your study will be contracted out. 我们处理所有协议设计, IRB提交和管理, 受试者招募及支付, 研究性能, 数据分析和, 验证性研究, 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, 使我们能够提供一流的服务, 完整的解决方案. 准备好开始对话? 今天就和我们联系吧.

Unparalleled regulatory and medical expertise

Successfully navigate complex regulations for devices, 穿戴, 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. im体育APP’s recognized and published industry leaders are among the primary authors of multiple monitoring equipment guidance documents and test specifications.

从研究设计到执行, 我们让麻醉师参与进来, 胸腔科, 和心脏病专家. Along with laboratories located on the Avista Hospital Medical campus near Denver, 科罗拉多州, and our vast network includes additional medical centers and hospital research partners. 要了解更多， 立即im体育APP.

优化和调整整个R算法&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.

im体育APP优势

Bring an optimal device to market quicker with industry-leading 临床验证 services. 我们的顾问工程师, 科学家们, 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 im体育APP by your side.

To learn more about 临床验证 testing of 穿戴 and medical devices, 今天就和我们联系吧.