Case Study: Ender Diagnostics builds a cloud-based eQMS and passes ISO 13485 audits with Qualio

How Ender Diagnostics' quality manager built an in vitro medical device QMS with Qualio

Ender Diagnostics, a Swiss developer and manufacturer of rapid molecular diagnostic kits for SARS-CoV-2, needed a more scalable quality management system as it grew quickly during the pandemic. Its manual, paper-based QMS couldn’t support audit-ready traceability, remote work, or the needs of a fast-moving medical device organization operating under ISO 13485 and IVDD/IVDR requirements. Qualio was chosen to help replace that approach with a cloud-based eQMS.

Qualio implemented a complete eQMS for Ender Diagnostics, including document control, training management, and quality event management, with support from Qualio’s team and compliant templates to speed setup. The company passed its ISO 13485 audits in February and April 2022, eliminated non-conformities related to document control, and enabled a more efficient hybrid workflow. With Qualio, Ender Diagnostics also improved user engagement, tripled headcount to over 180 while maintaining compliance, and created a single cloud-based source of truth for continued growth.

Ender Diagnostics

Mohamad El Zein

Quality Manager