Proven Process Medical Devices Inc. is one of the nation's leading designers and manufacturers of Class II and Class III medical devices. The company is an EN ISO 13485:2016 certified and FDA registered full-service outsourcing partner that offers exceptional design, development, validation and contract manufacturing services exclusively for the medical device industry. Founded in 1994, Proven Process exists to address the unmet need for an outsourced provider to the medical device industry with the in-depth technical, quality and regulatory knowledge needed to develop and manufacture sophisticated medical products. The company founders developed a "Proven Process” combining creative, state-of-the-art R&D with exceptional design, process, and quality controls to achieve new product development and manufacturing success.