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Introduction Electrocardiogram (ECG) machines are vital in diagnosing and monitoring various cardiac conditions. ECG machine certification is crucial in achieving these goals and building trust among healthcare providers and patients. Different countries have their regulatory bodies and requirements for medical devices.
The Zio monitor ECG System secured its CE mark based on compliance to EU MDR standards of performance, quality, safety, and efficacy, along with the body of clinical evidence supporting Zio in detecting potential cardiac arrhythmias. milla1cf Wed, 01/03/2024 - 12:09 January 3, 2024 — iRhythm Technologies, Inc. , Data on file. Hannun, AY.
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