How to Prepare for Clinical Trials of ECG Devices

This article introduces two mainstream principles used in respiratory signal testing, as well as how respiratory signal simulation technologies can support the verification of respiratory monitoring functions in patient monitors and wearable devices.

With the popularity of health wearable devices, major manufacturers around the world are facing a series of production line testing challenges in order to improve their product quality and production efficiency. These challenges not only affect product quality, but may also lead to a reduction in production efficiency.

Patient monitors face rigorous accuracy requirements established by the international medical standard IEC 60601-2-27, which governs ECG measurement precision. Factors like vibration, temperature, humidity fluctuations, and electromagnetic interference from nearby equipment can impact measurement accuracy. Standardized regulations are thus crucial to ensuring consistent ...