Case Study: Sentec achieves faster audit prep and stronger compliance with Qualio Compliance Intelligence

How Sentec cut audit prep by 80% with Compliance Intelligence

Sentec, a Swiss-American medical device company, needed a better way to manage compliance across demanding global regulations such as EU MDR, ISO 13485, and MDSAP. As a long-time user of Qualio’s eQMS software, the team wanted a more efficient way to identify compliance gaps and prepare for audits without relying on time-consuming manual searches.

Qualio’s Compliance Intelligence helped Sentec scan its QMS in 30–40 minutes, automatically surface gaps, and provide remediation recommendations across SOPs, policies, and records. The results included 5x faster audit prep, an 80% reduction in audit preparation time from one week to one day, two major process improvements, and greater audit confidence through stronger visibility and lower risk.

Sentec

Christophe Dohr

Site Quality Manager