MRI machines

Form: Closed MRI systems, Open MRI systems, Portable MRI units

Strength: High-field (1.5T and 3T) systems with advanced imaging capabilities

Reference Brands: Siemens, GE Healthcare, Philips, Canon Medical, Hitachi

Category: Medical Devices

MRI machines in the EU and US are regulated to guarantee safety, efficacy, and quality. In the US, FDA approval involves validation, clinical safety testing, and GMP compliance, while in the EU, CE marking certifies conformity with MDR standards. These systems undergo validation, stability testing, and audits, with comprehensive documentation including safety profiles, performance data, and manufacturing practices. For licensing procedures, approved dossiers, and the latest regulatory updates, visit Pharmatradz. Ensuring compliance guarantees access to reliable, high-performance MRI systems that support accurate diagnosis, patient safety, and effective clinical workflows worldwide, facilitating advanced medical imaging in healthcare facilities.