Built for SaMD startups, not enterprise QA departments

QualiHQ is a quality management system designed for Software as a Medical Device (SaMD) teams who need to meet ISO 13485, IEC 62304, and ISO 14971 requirements, the international standards behind both FDA and EU MDR, without the budget, headcount, or timeline that enterprise QMS platforms assume you have.

Most QMS tools are built for large regulated organisations with dedicated compliance teams and months to spend on onboarding. SaMD startups have none of that. They have a small engineering team, a tight runway, and a regulator waiting for a technical file.

QualiHQ is built for that situation. It uses AI to generate your requirements, verifications, SOPs, and traceability chain from your product description and test evidence. Your team reviews and approves everything.

The goal is simple: get SaMD teams audit-ready as quickly as possible, without disrupting how they build.

If you have feedback, we want to hear it.