Quality Assurance

A medical device engineer at Proven ProcessThe hallmark of Proven Process's success in the medical device and marketplace is our Quality System. Our company assures customer satisfaction and product safety through a robust and proven Quality System that is 21 CFR 820 FDA Quality System (QS) Regulation compliant and EN ISO 13485:2016 certified. Our comprehensive quality management system encompasses the essential elements necessary for the design, production, and distribution of innovative medical devices that meet today's challenging healthcare and cost containment needs.

From controlling and defining product design, production and processes, non-conforming product, and instituting corrective and preventive action to applying the ISO 14971:2007 risk management system for medical devices, Proven Process's foundation is quality suitable for Class III medical devices and systems and applicable to all classes of medical products.