synbrAIn has obtained ISO 13485 Certification, the standard for Quality Management of Medical Devices, placing patient safety at the center. This certification aims to standardize regulatory requirements for medical devices at an international level, as established by Directive 93/94 CEE.

This achievement confirms synbrAIn as a reliable company compliant with regulations. The certification was granted by Bureau Veritas after a rigorous assessment of legal requirements, certifying that the company is qualified to design, manufacture, install, and market safe and compliant medical devices.

ISO 13485 is essential for companies in the medical device sector and includes specific requirements for:

• Implementing a quality management system for continuous improvements;
• Managing risks in product development and manufacturing;
• Validating processes;
• Complying with legal and regulatory requirements;
• Ensuring product traceability and recall systems.

The acquired ISO 13485 Certification is valid for five years and adapts to the evolving needs of the sector. Thanks to this success, the company will continue its work in the field of digital healthcare.