Compliance testing is a critical step for any medical device before entering the market. According to the IEC 60601-2-25:2011 standard for diagnostic ECG devices, manufacturers and software developers are required to conduct digital tests using the CTS database. These tests employ ECG-like waveforms to evaluate algorithms through standardized signals, ensuring accurate measurements of amplitude, interval, and duration.

Since its establishment in 2013, WhaleTeq has been dedicated to providing high-quality testing equipment to assist medical device manufacturers in product development, particularly in overcoming the challenges of compliance testing. Corscience GmbH & Co. KG is a German defibrillation and monitoring expert with more than 20 years of experience. Corscience offers customized modular solutions and comprehensive development services for medical device projects combined with regulatory and technical consulting to ensure reliable, market-ready products. We are pleased to announce that after extensive discussions, WhaleTeq has officially partnered with Corscience and has been authorized to market the CTS database starting June 1, 2024.

The CTS database comprises 16 CAL files as calibration signals and 3 ANE files as analytical signals, all provided in digital format. Users input the CTS data into their ECG algorithms to verify whether the calculated results align with the IEC 60601-2-25:2011 requirements. For any discrepancies, users need to optimize algorithms and retest to meet the required accuracy.

Additionally, users can leverage WhaleTeq's CTS/CSE Database Compliance Analyzer (CDCA) software, which allows for direct comparison of test values with reference values, eliminating the inconvenience and errors associated with manual comparison. Through this partnership, WhaleTeq CEO Nathan Lin stated, "WhaleTeq and Corscience are committed to assisting manufacturers in smoothly conducting compliance tests, enabling them to focus resources on optimizing design and accelerating their products' time-to-market."

For more information, please visit the product page: CTS Database and CDCA