Quality Management System
At CapnoPharm, quality is at the core of everything we do. CapnoPharm GmbH operates a Quality Management System certified EN ISO 13485:2016 by TÜV SÜD. Our fully digital supported Quality Management System (eQMS) ensures efficiency, transparency, and continuous improvement across the entire product lifecycle.
Regulatory Affairs
Regulatory excellence is embedded in every stage of our work — ensuring safety, performance, and reliability. We operate in full alignment with the European Medical Device Regulation (EU) 2017/745 (MDR), including all requirements for Class IIb medical devices.
Feedback & Complaints
We value your feedback as a key driver of continuous improvement. To share positive feedback or report a complaint, please use our contact page.
Quality Management System
At CapnoPharm, quality is at the core of everything we do. CapnoPharm GmbH operates a Quality Management System certified EN ISO 13485:2016 by TÜV SÜD. Our fully digital supported Quality Management System (eQMS) ensures efficiency, transparency, and continuous improvement across the entire product lifecycle.
Regulatory Affairs
Regulatory excellence is embedded in every stage of our work — ensuring safety, performance, and reliability. We operate in full alignment with the European Medical Device Regulation (EU) 2017/745 (MDR), including all requirements for Class IIb medical devices.
Feedback & Complaints
We value your feedback as a key driver of continuous improvement. To share positive feedback or report a complaint, please use our contact page.