Viewing profile — enzymejacob

We believe the pre-cert pilot will be transformative for both FDA and digital health companies. FDA is learning from some of the largest software companies how they manage their pr…

Enzyme is hosted in a 'private cloud' for each customer to ensure compliance and data isolation.

Our QMS is an all-inclusive electronic QMS, or eQMS. All quality sub-systems including Document Control, Design Control, Risk Management, Complaint Handling, CAPA, etc. will be int…

Most of our early customers have 510(k) products, which are typically less burdensome to commercialize in the US vs obtaining CE marking.