Case Study: Establishment Labs achieves a paperless, cloud-based quality system and stronger regulatory compliance with ComplianceQuest

Establishment Labs Abandons Manual Processes, Embraces ComplianceQuest’s Market-Leading Enterprise Quality Management Platform

Establishment Labs, a global femtech medical device and aesthetics company, faced a cumbersome, paper-based quality management system—Microsoft Word/Excel files, printed forms, manual signatures and mail-based training—that couldn’t scale with rapid growth or meet strict regulatory demands. After an initial QMS implementation fell short, they chose ComplianceQuest and began rolling out ComplianceQuest’s Salesforce-native Enterprise Quality Management System (Document, Change, and Training modules) to modernize and centralize quality processes.

ComplianceQuest delivered a cloud EQMS with integrated document control, change management, and training workflows that enabled remote work, audit transparency, and tighter governance. Since going live in January 2019, Establishment Labs has created 1,837 new documents, made 3,651 document changes, completed 76,600 trainings, recorded 17,000 electronic approvals, and eliminated roughly 50,000 sheets of paper—measurably improving efficiency, traceability, and regulatory readiness.

Establishment Labs

Gabriela Campos

Quality Systems Manager