Proven Process is a leader in the design, development, validation, and manufacture of Class II & III medical devices. Founded in 1994 to address an unmet need for an outsourced provider with in-depth technical, manufacturing, quality and regulatory knowledge, PPMD provides "one stop shop" services to leading global medical device OEM's, emerging companies and start-up ventures. Our customers will tell you that we do it all – and do it exceptionally well. 

Our medical device design and manufacturing brochure is hot off the press. It features a complete rundown of our services and capabilities. Download our medical device manufacturing and design brochure.

At Proven Process Medical Devices, our current certification is according to EN ISO 13485:2016. Many of the changes in ISO 13485:2016 are intended to bring medical device manufacturing in line with other standards related to risk management during the design, production, and validation phases.

Read more about 13485-2016

Our work ranges from complex cardiac devices to in-vitro diagnostic devices to disposables, active implantables, robotics and all kinds of sterile kits. We invite you to browse our medical device portfolio. Take a virtual tour of our Mansfield, MA facility here.