Medical Device Manufacturing - Overview

HEI Boulder Medical Device Manufacturing plant prides itself to be able to take your ideas and convert them to an actual product launched quickly and successfully in your medical market place.

HEI Boulder is certified to FDA regulations: FDA QSR Class I, II, & III; ISO 14971; and ISO 13485.

We design products that meet your requirements, are designed for manufacturing, and are compliant to FDA regulations. We cater to all of your hardware, and software requirements. 

Together, we will make your company and your product successful.

Contact HEI today for the best in Medical Device Manufacturing of Class I, II & II electronic medical devices.