Ender Diagnostics' manufacturing sites, as well as its testing laboratories in Bern and Zurich, now access Qualio as the company's dedicated electronic quality management system.
Ender faced its ISO 13485 audits in February and April 2022 and passed with flying colors, unlocking new regulated markets to Ender for the first time.
With digitally enforced compliance, the organization can now focus on further market expansion and has begun work on territory-specific requirements.
The headcount of Ender Diagnostics has already tripled to over 180 employees since Mohamad joined, making a cloud-based single source of truth vital for continued compliance and quality improvement.
Ender now has ambitious plans for bringing fresh products to market, with 3 more in the pipeline and an SaMD project in the works too.
Above all, Mohamad has embedded the control, consistency and traceability he felt was impossible in a paper-based quality framework - and has made his own life easier in a hybrid working world.
By using Qualio’s DMS we were able to eliminate all non-conformities related to our document control.
The office is 3 hours from my house so I do lots of work at home and on the train, and you can imagine my backpack full of paper before Qualio.
Forget it! COVID showed us you must have the possibility to work from anywhere.
Mohamad has seen a noticeable uptick in engagement with the quality system, with more Ender employees comfortably accessing and completing quality tasks within Qualio than the previous system.