Case Study: SimBioSys achieves 510(k) clearance in 90 days with Qualio

SimBioSys builds a market-ready QMS in 90 days with Qualio

SimBioSys, a developer of a Class II software as a medical device (SaMD) platform for computational oncology, needed FDA 510(k) clearance but lacked a functional quality management system and internal regulatory expertise. Their challenge was to quickly build a market-ready QMS from the ground up. Vice President Hilary Baldwin sought an easy-to-use electronic quality management system (eQMS) and began searching for a vendor, ultimately selecting Qualio.

Qualio provided its eQMS software, which was implemented and fully built out within 90 days. The solution centralized document access and training for the entire team and provided support for pursuing multiple standards simultaneously. As a result, SimBioSys secured successful FDA 510(k) clearance for its TumorSight platform in December 2023, replacing clunky Excel-based processes with a streamlined, collaborative system.

SimBioSys