ISO-13485 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 13485-2016 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.

Proven Process has successfully completed the requirements of an ISO 13485-2012 Surveillance AuditISO 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 its 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.

Download our EN ISO 13485-2016 Certificate

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.