Angiolutions receives ISO 13485 certification for its fully digital quality management system

Ensuring highest quality and safety standards for the world’s first device to treat small abdominal aortic aneurysms

Quality management at Angiolutions driven by fully digital, paperless system

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As of February 7, 2022, Angiolutions is ISO 13485 certified. This ensures highest levels of quality and patient safety in our journey to bring the first device to treat small abdominal aortic aneurysms (AAAs) to market and to help hundred thousands of patients.

ISO 13485 is a standard detailing a comprehensive quality management system for medical device manufacturers. It helps us achieve excellence in our operations and makes sure that we follow the latest standards and regulations.

Furthermore, the ISO 13485 certification constitutes a key step towards regulatory approval and the launch of our novel device.

“At Angiolutions we have the ambition to bring our ground-breaking device to patients as fast as possible, while ensuring highest levels of quality at every step of the way. Thus, we need efficient and modern processes.” said Dr. Isabel Schellinger, CEO and co-founder of Angiolutions.

Angiolutions ISO 13485 certification
Therefore, we committed ourselves to go the extra mile and to implement a fully paperless, digital and scalable system together with our partner qmBase

Our quality management system now ensures robust, fast and efficient procedures to maximize patient safety and operational excellence, while at the same time efficiently managing risks all across our company. 

The audit was conducted thoroughly and efficiently by DQS.  

“Thanks to our motivated team and DQS as an engaging sparring partner we have achieved ISO 13485 certification within our ambitious schedule.” stated Dr. Uwe Raaz, CEO and co-founder of Angiolutions. 



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