QualiPilot

QualiPilot is an AI‑powered, multi‑tenant SaaS platform that streamlines end‑to‑end medical device commercialization by combining secure, cloud‑hosted workspaces with Retrieval‑Augmented Generation (RAG) chat to deliver context‑aware guidance. When a user sends a message, we generate embeddings via OpenAI’s embedding model and perform vector similarity search across the user’s uploaded documents, eCFR regulatory sections, and ISO 13485 standards.

This RAG approach ensures every answer is grounded in actual regulatory content and your own documentation—helping MedTech teams accelerate FDA 510(k) and CE MDR submissions while maintaining ISO 13485 and HIPAA compliance .