Greenlight Guru

“We passed our last audit” no longer guarantees you’re safe in 2027. The rules changed in 2026 for risk-based inspections, new records in scope, and AI-fueled oversight. At our Virtual Summit on 2027 Readiness, we’ll walk through what’s different, where FDA and customers are headed next, and how to assess if your current quality system will hold up when the next inspection or review hits.

Meet Ultralight. The new QMS from Greenlight Guru that your product development engineers will actually use.

Greenlight Guru's QMS Software revolutionizes the way medtech companies handle compliance. With pre-validated workflows and built-in regulatory expertise, you can reduce audit risks and achieve faster results without compromising accuracy. Streamline your team's collaboration and focus on innovation confidently.

Early-stage medtech teams need to move fast. Ultralight helps you stay compliant and move toward your next milestone faster.

Ultralight gives medtech teams a QMS that flexes with the way they work. Simple, fast, and audit-ready. No heavy setups, no rigid workflows. Just a clear path to submission.

Ultralight links requirements, risks, and testing into one flexible system. SaMD and SiMD teams use it to reduce rework, simplify audits, and keep development moving without extra overhead.