Quality Management System & Regulatory Submission Platform

A complete solution for your quality and regulatory needs

Enzyme QMS

Our software includes modules for all stages of the product development life cycle from Design Control to CAPA.

Services

Our in-house experts are here to back you up! We can guide you through the quality challenges and regulatory submission process.

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Designed for life science, optimized for SaMD and Digital Health

Streamlined QMS

A QMS that includes modules for all stages of the product life cycle from Design Control to CAPA

Integrates with existing tools

Enzyme QMS integrates with your existing tools, such as JIRA, GitHub and Jenkins with Enzyme

In-depth Onboarding

We train your entire team and provide you with support when and as it's needed

Trusted by

Maria Chacon-Heszele

Biomeme

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.”

Henry Mancke

Posit Science

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.”

Steve Badelt

Suttons Creek

A simple, intuitive solution for running a lean team while staying compliant.”

Enhao Gong

Subtle Medical

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.

Maria Chacon-Heszele

Biomeme

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.

Henry Mancke

Posit Science

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.

Trusted by

Maria Chacon-Heszele

Biomeme

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.”

Henry Mancke

Posit Science

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.”

Steve Badelt

Suttons Creek

A simple, intuitive solution for running a lean team while staying compliant.”

Quality Management System and
Regulatory Submission Platform

‍ Get your product to market faster

A complete solution for your quality and regulatory needs