FDA Compliance made simple

Enzyme provides FDA compliance & quality systems as a service, coupling a cloud-based software solution with tailored support.

We help you get to market faster with less risk by taking the guesswork out of the paperwork process.

510k? PMA? QMS? Audits? NC? CAPA?

Navigating the world of regulatory compliance as a medical device startup is a challenging process. If you feel like you need a master's degree in compliance just to figure out what you need to do, you're not alone.

A recent survey of medical device executives ranked navigating the regulations the #2 challenge they faced, second only to raising capital.

We're here to help.

No IT required

Our system is 21CFR Part 11 compliant AND based in the cloud.

Integrates with your existing tools

Already using JIRA, Trello or GitHub to store parts of your system? Don’t re-enter data twice, our system integrates with popular tools out of the box.

Easy to Deploy and to Use

We can on-board your company in a week and training takes a day, not a month

Trusted by

Supported by

Rock Health YCombinator Refactor Capital Soma Capital DCVC

We're hiring!


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