Case Study: Gilero achieves streamlined management of multiple FDA-regulated sites with Intellect

Medical Device Design, Development & Manufacturing Company Gilero Continues Growth with New Configurable QMS Solution

Gilero, a North Carolina–based medical device design and contract manufacturing firm founded in 2002, grew from a single-site operation into a global company working with FDA- and internationally regulated customers. As the business expanded, its paper-based Quality Management System became increasingly complex and time-consuming to manage, and the team needed an electronic solution that didn’t require coding expertise.

Gilero selected Intellect’s no-code eQMS, initially deploying Document Control and Employee Training apps—customized to match its document numbering and training workflows—and is rolling out Calibration & Maintenance next. The platform streamlined processes, improved cross-site collaboration between engineers and quality staff, reduced errors, made information easier to find, and earned positive feedback from users across the organization.

Gilero

Kristin Benokraitis

Director of Quality and Operations