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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 aggressively entering the digital health marketplace, so their participation in the pilot alongside large traditional drug and device companies J&J and Roche will be tremendously informative for FDA. Smaller companies on the forefront of digital health approvals such as Pear Therapeutics, Phosphorous and Tidepool will round-out FDA's understanding of how subsequent guidance documents will impact startups in this space. Whether products are SaMD or software-enabled, this industry is on the cusp of exploding with FDA's recent open and progressive approach toward fostering innovation.

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 integrated.

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