Quality System & Certification

Proven Process Medical Devices, one of the nation’s leading designers and manufacturers of Class II and Class III medical devices, has successfully completed the requirements of an ISO 13485-2003 Surveillance Audit. The audit confirms and renews Proven Process Medical Devices’ long-held 13485 certification and further underscores the company’s commitment to excellence at every stage of medical device development and manufacturing process which it employs.

ISO 13485 is an internationally recognized standard of quality, which articulates the stringent requirements of the Quality Management System (QMS) for the design and manufacture of medical devices. Based on better-known ISO 9001 standards, ISO 13485 requires heightened attention to the regulatory requirements associated with the design, development and manufacture of medical devices. Proven Process first earned ISO 13485 certification in 2002.

“Our commitment to adding real and measurable value at any and every stage of medical device development in which we participate depends heavily on our understanding of and adherence to the quality standards put forth by ISO 13485. We take great pride in the results of this ISO surveillance audit and use it as an occasion to renew our company’s cultural commitment to quality and excellence,” stated Kenneth Fine, President of Proven Process Medical Devices.

You may download our ISO 13485 Certificate here.

About ISO: ISO is the International Organization for Standardization. It was established 1947 and is located in Geneva, Switzerland. Its purpose is to facilitate and support international trade by developing standards that people everywhere would recognize and respect. ISO achieves this purpose through the participation and support of its member bodies representing some 150 countries. ISO standards tend to have worldwide support.

About ISO 13485: ISO 13485 was developed by ISO Technical Committee 210 which is responsible for quality management and corresponding general aspects for medical devices.

About Proven Process Medical Devices: Founded in 1994, Proven Process Medical Devices is expert in the design, development, validation, and manufacture of Class II and Class III therapeutic and diagnostic medical devices. The company adheres to a process that has proven successful since its inception in 1994. The company’s Concept to Customer(sm) Turnkey Service allows it to provide value through any and every step of the medical device development process. Proven Process clients include high profile brands such as Boston Scientific and Pfizer as well as promising start-ups poised to make their names in the industry.