Quality Management System and
Regulatory Submission Platform
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A complete solution for your quality and regulatory needs
Designed for life science, optimized for SaMD and Digital Health
Streamlined QMS
Integrates with existing tools
In-depth Onboarding
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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.
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.
I would recommend Enzyme to anyone, especially companies looking to implement (or improve the efficiency of) a quality management system.
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.
I highly recommend Enzyme to any digital health startup that needs to comply with FDA regulations.
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