What is Enzyme?
Enzyme is an AI-powered Quality Management System (QMS) platform built specifically for innovators in the medical device, digital health, and biopharmaceutical sectors. It simplifies compliance with critical regulatory standards including cGMP, FDA's QSR, and ISO 13485 by automating quality workflows across the entire product lifecycle. From early-stage design to post-market surveillance, Enzyme centralizes quality operations—offering intelligent tools for document control, risk assessment, audit readiness, and corrective actions—so teams can focus on innovation without compromising compliance.
How to use Enzyme?
Getting started with Enzyme is simple: request a personalized demo to see how the platform aligns with your quality goals. After onboarding, migrate your legacy data effortlessly and connect Enzyme to your existing tech stack through seamless integrations. Navigate intuitive modules tailored to your operational needs—such as training management, change requests, or supplier evaluations—with AI-driven guidance that adapts to your processes. Whether you're managing design inputs or closing out CAPA records, Enzyme supports a scalable, compliant workflow that evolves with your business.