ECG machines

Form: Resting ECG machines (manual and digital), Stress ECG systems, Holter monitors, EHR-integrated digital systems

Strength: High-resolution digital outputs

Reference Brands: GE Healthcare, Philips, Schiller, Cardiospec

Category: Medical Devices

ECG machines in the US and EU are regulated to ensure safety, accuracy, and performance. In the US, FDA approval requires comprehensive clinical validation and compliance with medical device regulations, while in the EU, CE marking certifies conformity with in vitro diagnostic and medical device standards. These devices undergo validation, stability testing, and thorough audits, with detailed documentation including safety profiles, clinical data, and manufacturing practices. For licensing procedures, approved dossiers, and the latest regulatory updates, visit Pharmatradz. Ensuring regional compliance guarantees access to reliable, accurate ECG systems vital for cardiac diagnosis, patient monitoring, and healthcare delivery worldwide.