Enzyme

Founded 2017

Manage medical device quality compliance and regulatory documentation throughout product lifecycles

You can use Enzyme to manage regulatory compliance and quality assurance across the product lifecycle. The system organizes standard operating procedures, tracks employee training requirements, and oversees design controls for life sciences and medical technology teams. You can also handle document revisions, manage change controls, and monitor supplier evaluations. When issues arise, it lets you document nonconformances, investigate customer complaints, record internal audits, and guide corrective and preventive actions (CAPA) to meet FDA and ISO standards from early-stage development through commercial release.

What Enzyme does

Route documents for electronic signaturesAssign regulatory training modules to team membersLog customer complaints and track investigationsCreate risk management traceability matricesManage CAPA workflows from root cause to verificationSchedule and record internal quality auditsReview and approve engineering change ordersTracks document versions and approval routingManages employee training records and curriculum sign-offsDocuments design controls and risk analysis matricesTracks corrective and preventive actions (CAPA)Records customer complaints and post-market feedbackCoordinates internal and external compliance auditsLogs supplier evaluations and vendor qualification data

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