Case Study: Restech achieves paperless quality management and audit-ready compliance with Qualio

Restech cuts QMS admin time by 9.5 days with Qualio

Restech, a medical device company producing diagnostic and treatment tools for reflux disorders, faced a significant challenge with its manual, paper-based quality management system. This process was a tremendous time and resource drain, hindering growth and complicating compliance with standards like FDA 21 CFR 820 and ISO 13485. The company's Director of Quality Assurance, Lowell Hoffman, sought an electronic QMS (eQMS) solution to overcome this, ultimately selecting the Qualio platform.

By implementing Qualio's eQMS, Restech was able to automate its document control and compliance processes. The results were immediate and impactful, freeing department leads from full-time QMS upkeep and enabling a perfect ISO 13485 audit with zero non-conformances. The measurable impact included a dramatic reduction in administrative overhead, saving an estimated 9.5 days in document process time. Confident in the success of their Qualio investment, Restech is now expanding its use to prepare for entry into new international markets.

Restech