Navigating the world of regulatory compliance as a medical device startup is a challenging process. If you feel like you need a master's degree in compliance just to figure out what you need to do, you're not alone.
A recent survey of medical device executives ranked navigating the regulations the #2 challenge they faced, second only to raising capital.
Our system is 21CFR Part 11 compliant AND based in the cloud.
Already using JIRA, Trello or GitHub to store parts of your system? Don’t re-enter data twice, our system integrates with popular tools out of the box.
We can on-board your company in a week and training takes a day, not a month
Enzyme has vastly exceeded any of my expectations in helping us get started in setting a compliant QMS.
After cycling through several consultants who did not meet our needs, Enzyme's tools and customer support team struck exactly the right balance to help us navigate the process of learning how to adapt our existing work processes into compliant workflows while maintaining company culture.
I would recommend Enzyme to anyone, especially companies looking to implement (or improve the efficiency of) a quality management system.”
We'd been struggling for months to find a compliance solution that worked for our software medical device before we ran into Enzyme. We evaluated a range of consultants and other software solutions and found Enzyme to be the best fit for us.
I highly recommend Enzyme to any digital health startup that needs to comply with FDA regulations.”
A simple, intuitive solution for running a lean team while staying compliant.”
CEO & Cofounder
Jared is an 11 year veteran of the medical device and biopharma industries, with a background in product management, medical device software, design assurance and regulatory strategy. His experience ranges from leading spinal cord stimulator programs at St. Jude Neuromodulation (now Abbott), to the UI/UX for the first hybrid closed loop insulin pump at Medtronic Diabetes, to the regulatory strategy for numerous combination drug-device products, including Amgen's Neulasta Onpro and Repatha Pushtronex. Prior to his experience in the life sciences he trained and worked as a software engineer.
He holds a BA from the University of Colorado and an MS in Medical Device Engineering from USC.
Jacob Graham, CBA, RAC
VP QA/RA & Cofounder
Jacob is an 11 year veteran of the medical device industry, with a background in quality management, design assurance, and audit planning. He has helped commercially launch several Class II and III devices and has overseen multiple FDA and EU notified body audits. Prior to co-founding Enzyme he held quality management positions at Medtronic and Boston Scientific.
Jacob has an MBA from Babson College and a BS in Engineering from Olin College.
Additionally he has achieved several professional certifications in the life sciences, and is an ASQ Certified Biomedical Auditor and RAPS Regulatory Affairs Certified (US).