Patient Monitors

Form: Multiparameter monitors, Vital signs monitors, Portable and bedside units

Strength: High accuracy, integrated data management

Reference Brands: Philips IntelliVue, GE Healthcare, Nihon Kohden, Masimo, Zoll

Category: Medical Devices

Patient monitors in the EU and US are regulated to ensure safety, accuracy, and device performance. In the US, FDA approval involves clinical validation, safety assessments, and GMP compliance. In the EU, CE marking certifies conformity with the Medical Device Regulation (MDR). Devices undergo validation, stability testing, and audits, with comprehensive documentation including safety profiles, clinical trial data, and manufacturing practices. For licensing procedures, approved dossiers, and latest regulatory updates, visit Pharmatradz. Ensuring compliance guarantees access to reliable, safe patient monitoring systems vital for accurate diagnosis, patient safety, and effective clinical decision-making across healthcare and veterinary sectors worldwide.