Gilbert would like to acknowledge the monumental achievement of the entire team in attaining the ISO 13485:2016 certification by TÜV SÜD, demonstrating the company’s commitment to compliance with the highest level of internationally recognized quality standards.
“We are proud of the robust quality management system our team has built, ensuring stringent control over design and development processes,” said Maurits Huigen, Chief Executive Officer of Gilbert. “This certification demonstrates our ability to meet exacting regulatory requirements as we continue to achieve the developmental milestones for our Smart Precision Inhaler platform.”
Gilbert successfully completed audits by TÜV SÜD to verify that it has established and is maintaining a quality management system that meets all requirements of the ISO 13485:2016 standard for design and development of Gilbert’s products.
ISO 13485 is an internationally recognized quality standard for quality management systems, created by the International Organization for Standardization to ensure the safety and effectiveness of medical devices. It builds on the ISO 9001 standard with additional regulatory requirements specific to medical devices. In 2025, the U.S. Food and Drug Administration issued the Quality Management System Regulation (QMSR) Final Rule, which harmonizes U.S. requirements with global standards through the adoption of ISO 13485 standards for medical devices.