The Spanish company will strengthen its commitment to safety, traceability, and continuous improvement

PhysioMRI, a company dedicated to the research and development of portable magnetic resonance imaging systems, is about to receive ISO 13485 certification, an international standard that accredits quality and safety in the design and manufacture of medical devices. This achievement represents a decisive step in consolidating the company as a technological benchmark in the advanced medical imaging sector.

The ISO 13485 standard establishes the requirements that quality management systems applied to medical devices must meet, from the initial stages of research to production, distribution, and technical support. Its purpose is to ensure that each product is developed under controlled, reproducible processes focused on patient and user safety. For PhysioMRI, this certification represents external validation of the methodological rigour with which it has been working on the development of its portable magnetic resonance imaging devices, a technology that promises to transform clinical and research environments.

The certification process has involved a comprehensive review of internal procedures, technical documentation, quality controls, component traceability and risk management mechanisms. The company has strengthened its verification and validation protocols, optimised its workflows, and adopted new control tools to ensure the reliability of each of the subsystems in its portable MRI equipment. Thanks to these improvements, PhysioMRI not only complies with international regulatory standards, but also increases the efficiency and consistency of its operations.

One of the most important aspects for PhysioMRI is that ISO 13485 does not merely validate the final product, but also requires an organizational culture focused on quality. This includes staff training, document management, supplier validation, manufacturing process control, and the implementation of clear post-marketing surveillance protocols. For a technology as sensitive as portable MRI, these criteria are essential to minimize risks and ensure reliable clinical performance.

In addition, obtaining ISO 13485 certification facilitates the entry of this new MRI into international markets. Many regulatory bodies, such as the FDA in the United States or the European Medicines Agency (EMA), consider this standard to be a prerequisite or a key element in approval dossiers. In this way, certification becomes an accelerator for technology transfer, allowing the device to reach hospitals, clinics, and research centers with the necessary guarantees.

ISO 13485 certification represents a strategic milestone for PhysioMRI. It marks the beginning of a new era in which innovation, quality and safety come together to drive the next generation of portable MRI systems.