The only QMS as innovative as you

Enzyme QMS is 21 CFR Part 11 compliant, validated out-of-box, and offers an industry-leading number of integrations so you can keep using the tools you love. Designed to scale as you scale, Enzyme supports the full product lifecycle, making it the only QMS you’ll ever need.

Trusted by

Enzyme QMS empowers innovation
across the life sciences

Our quality management system software serves medical device, digital health, and biopharma companies


Enzyme QMS has everything you need, premarket to postmarket, startup to IPO.


Enzyme adapts to your way of working, not the other way around.


Our QMS software is continuously evolving to better meet your needs.


Designed by quality & regulatory professionals, for quality & regulatory professionals.

Work your way with Enzyme QMS

Designed for modern workflows, Enzyme's quality management system integrates with your existing tools so you can easily import your data. You can also generate reports directly from our eQMS.
Comparing how we did QMS at GeneWEAVE without Enzyme and how we do things now is night and day.
Diego Rey, Chief Scientific OfficerEndpoint Health
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.
Enhao Gong, CEOSubtle Medical
The care and thought the Enzyme team has put into designing and implementing the eQMS has made our lives one thousand times easier.
Judy Brimacombe, VP Clinical, QA, RADawnLight Technologies