enzymejacob

5 ms·

1. 1.▲
   by enzymejacob 9y ago

   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 product life cycles. Apple, Verily and Samsung are aggressivel
2. 2.▲
   by enzymejacob 9y ago

   Enzyme is hosted in a 'private cloud' for each customer to ensure compliance and data isolation.
3. 3.▲
   by enzymejacob 9y ago

   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 integrated.
4. 4.▲
   by enzymejacob 9y ago

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