Quality Management System and

Regulatory Submission Platform

‍ Get your product to market faster

*Enzyme’s mission is to automate and simplify life science regulatory approval and compliance. We reduce your cost of compliance and help bring your cutting-edge technology to market faster.Our cloud based Quality Management System (QMS) streamlines documentation and integrates with tools you are already using. And our experts guide you through your entire regulatory and compliance lifecycle: fro.

A complete solution for your quality and regulatory needs

Designed for life science, optimized for SaMD and Digital Health

Integrates with existing tools

Enzyme has vastly exceeded any of my expectations in helping us get started in setting a compliant QMS

After cycling through several consultants who did not meet our needs, Enzyme's tools and customer support team struck exactly the right balance to help us navigate the process of learning how to adapt our existing work processes into compliant workflows while maintaining company culture

We'd been struggling for months to find a compliance solution that worked for our software medical device before we ran into Enzyme We evaluated a range of consultants and other software solutions and found Enzyme to be the best fit for us

As an early-stage healthcare technology company, we need to be both thorough and efficient The team at Enzyme has helped us streamline our quality process and post-market compliance, including our QMS process Their level of professionalism and service has been outstanding

I would recommend Enzyme to anyone, especially companies looking to implement (or improve the efficiency of) a quality management system

I highly recommend Enzyme to any digital health startup that needs to comply with FDA regulations

Start with Enzyme today