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

SimBioSys - Customer Case Study

SimBioSys, a developer of a Class II SaMD platform for computational oncology, faced a blank-slate regulatory challenge: no internal regulatory expertise, no functioning quality management system, and only a handful of documents in OneDrive. The VP of Regulatory & Quality opted for a digital eQMS and selected Qualio to manage documents, training, events and design controls to rapidly build a compliant QMS.

Qualio delivered a fast, easy-to-validate eQMS plus targeted Qualio+ support and templated content, enabling SimBioSys to have first users within a month and a complete QMS built in 90 days. The implementation centralized 110 QMS documents, reclaimed an estimated 20 hours of quality admin per week, cut marketization prep by one month, and made the company ready for its 510(k) submission in 90 days.

SimBioSys

Hilary Baldwin

VP of Regulatory & Quality