Enzyme QMS adapts to your workflow, not the other way around.
Enzyme QMS supports the full product lifecycle, premarket to postmarket.
With Enzyme’s quality management system, you’ll onboard in weeks, not months.
Enzyme QMS offers an industry-leading number of integrations.
Whether it’s setting up your first quality management system and developing your design history file or acting on your behalf with FDA, Health Canada, EMA, and notified bodies, we can assist with any quality or regulatory challenge. Our team has dealt with hundreds of audits and handled dozens of regulatory submissions from 510(k)s to NDAs.