Quality Management System and
Regulatory Submission Platform
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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.
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 ScienceWe'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 CreekA simple, intuitive solution for running a lean team while staying compliant.”
Henry Mancke
Posit ScienceWe'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.
Maria Chacon-Heszele
BiomemeEnzyme 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.
Steve Badelt
Suttons CreekA simple, intuitive solution for running a lean team while staying compliant.
Trusted by
Maria Chacon-Heszele
BiomemeEnzyme 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 ScienceWe'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 CreekA simple, intuitive solution for running a lean team while staying compliant.”
