Proven Process Medical Devices

Proven Process Medical Devices, Inc. is one of the leading designers and manufacturers of Class II and III medical devices in the United States. The company is an EN ISO 13485:2016 certified and FDA-registered full-service outsourcing partner, providing exceptional design, development, validation, and contract manufacturing services to the medical device industry. Founded in 1994, Proven Process was established to meet the unmet needs of the medical device industry for outsourcing providers through deep technical, quality, and regulatory expertise required for the development and manufacturing of complex medical products. The company's founders developed a "proven process" that combines innovative, advanced R&D with excellent design processes and quality control to ensure successful new product development and manufacturing.