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Enzyme provides FDA compliance & quality systems as a service, coupling a cloud-based software solution with tailored support.
We help you get to market faster with less risk by taking the guesswork out of the paperwork process.
510k? PMA? QMS? Audits? NC? CAPA?
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.
We're here to help.
No IT required
Our system is 21 CFR Part 11 compliant and based in the cloud
Integrates with your existing tools
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
Easy to Deploy and to Use
We can on-board your company in a week and training takes a day, not a month
Regulatory Compliance for the Rest of Us
QMS, MDR, CAPA, NC, ISO 13485, 21CFR820, 510(k), PMA. Navigating the world of regulatory compliance is not only a game of alphabet soup, it's also an ongoing challenge.
If you're a founder of a medical device or diagnostic company and wondering 'how does anyone make sense of this', you're not alone.
At Enzyme, we're building software that helps companies gain and maintain their compliance without burying them in a ton of paper forms or charging six-figure consulting fees
Our first product is a quality management system (QMS) tailor-made for medical device companies
Designed for a 21st Century Workflow
It's 2018, but some medical device companies act as if it's 1995. They generate their quality documentation by printing out Word documents, applying wet signatures, and storing them in a file cabinet.
At Enzyme we think that's crazy. Our software fits into a 21st Century Workflow. Run your compliance workflow the way you run every other workflow - via a cloud-based app you can reach anywhere.
Our solution works within your existing workflow - integrating with GitHub, Trello, Bitbucket, CircleCI and more. Don't have your team repeat work just for the sake of compliance.
Always Up-to-Date
We keep the app constantly updated to account for changes in regulations. ISO 13485:2016? Our app is currently compatible with the new standard. The new EU MDR? We’re on it.
Focus on improving clinical outcomes for patients, not the latest regulatory news
Trusted by
Maria Chacon-Heszele
Biomeme
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.”
Henry Mancke
Posit ScienceWe'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.”
Steve Badelt
Suttons CreekA simple, intuitive solution for running a lean team while staying compliant.”
Supported by
Leadership
Jared Seehafer
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).
