Jacob and I started Enzyme in 2017 with a mission to empower life science companies to innovate better and faster. We set out to build the system we wished had existed during our time in engineering (myself) and quality (Jake)—addressing the exact gaps we once faced firsthand. I’m deeply proud of how over the past...
The FDA third-party review program for 510(k) devices, known as 3P510k, may be revived if recent signals from the agency and Capitol Hill are any indication. While we at Enzyme do not see the 3P510k program as a universally faster path to market for all 510(k) filings, recent developments suggest that this program could once...
By Shawn M. Schmitt Communications Specialist, Enzyme When the US Food and Drug Administration (FDA) begins auditing MedTech companies under the new Quality Management System Regulation (QMSR) in 2026, the agency’s facility investigators will be looking for more than simply ticking off compliance checkboxes. They will expect companies to demonstrate a culture of quality, where...
Electronic Quality Management System
Enzyme eQMS is flexible and scalable, making it easy to use for startups, yet configurable to meet the needs of the most complex enterprise
