Re:Launch HN: Enzyme (YC S17) – Automating FDA Compliance an...
by notlob on Thursday January 18, 2018 @06:56PM
(#16182794)
Will this be self-hosted? Also, why FDA first instead of CE?
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Re:Launch HN: Enzyme (YC S17) – Automating FDA Compliance an...
by enzymejacob on Thursday January 18, 2018 @07:06PM
(#16182860)
Enzyme is hosted in a 'private cloud' for each customer to ensure compliance and data isolation.
Re:Launch HN: Enzyme (YC S17) – Automating FDA Compliance an...
by enzymejacob on Thursday January 18, 2018 @07:01PM
(#16182831)
Most of our early customers have 510(k) products, which are typically less burdensome to commercialize in the US vs obtaining CE marking.