Case Study: Fix the Mask achieves rapid FDA-ready market launch with Qualio Plus by Qualio

Fix the Mask turns to Qualio Plus to bring a medical device to market during the pandemic

Fix the Mask, a California nonprofit created to improve mask fit with its Essential Mask Brace, faced urgent regulatory hurdles as it tried to bring a medical device to market during the COVID‑19 pandemic. CEO Sabrina Paseman needed a robust QMS and FDA submission support quickly, and selected Qualio’s cloud-based eQMS, choosing Qualio Plus (Qualio’s quality-as-a-service) to get hands‑on Quality Assurance expertise alongside the platform.

Qualio Plus delivered a turnkey QMS, seamless onboarding, weekly expert support, and helped Fix the Mask define streamlined processes and target regulatory submissions. With Qualio’s guidance the team moved quickly to market and established a scalable QMS aligned with regulatory expectations—advancing toward 510(k) submission readiness and compliance with standards such as ISO 13485:2016, FDA 21 CFR 820 and ISO 14971:2019.

Fix the Mask

Sabrina Paseman

Chief Executive Officer