Recently, InVera Medical successfully attained the ISO 13485:2016 certification from BSI (British Standards Institution), an international notified body. ISO 13485 is an internationally recognised standard for quality management systems within the medical device industry. This achievement marks a crucial milestone preceding the market approval and registration of our InVera device in both the United States and Europe.
Expressing the significance of this accomplishment, Stephen Cox, CEO of InVera Medical remarked, “This certification is a testament to the culmination of years of dedicated effort, transforming our groundbreaking solution – the world’s first medical device to utilise the body’s biological response to treat varicose veins and venous ulcers without harmful side effects and translated that into an internationally recognised platform that is ready for manufacturing and human use”.
Aisling O’Sullivan, Director of Regulatory and Quality, played a pivotal role in initiating, developing, and executing the Quality Management System with the support of the InVera Medical team. Commenting on the announcement she emphasised, “ISO 13485:2016 certification establishes a robust foundation for the company to meet our customer requirements, ensure regulatory compliance, and foster excellence in day-to-day operational practices. Importantly, it represents a key step in delivering on our core values of patient safety.”
We are thrilled that InVera Medical have been awarded the ISO 13485 qualification, affirming our commitment to maintaining a Quality Management System that consistently meets customer and regulatory standards throughout the InVera device’s lifecycle. With ISO 13485:2016 certification, the InVera Medical team will continue to increase its investment in quality management, delivering high-quality design, development, and manufacturing that not only meets but exceeds all specifications and regulatory requirements but makes product safety one of the company’s highest priorities.
*Investigational device not for sale in US or any international markets