Enzyme's QMS is built specifically for medical device startups, especially those operating at the cutting edge of digital therapeutics and software-as-a-medical device (SaMD).

Design Control

Automatically ensure traceability throughout your entire design and development process.

Create your traceability matrix in minutes while spending less time maintaining it later.

Verify completed tests and approved or changed product requirements electronically.

Generate your Design History Files (DHF) with the click of a button.

Manage all controlled documents, records and SOPs in a secure location.

Electronic signatures, audit trails, and role-based security with enhanced password protection.

Effective document revision and change control with complete history tracking.

Automated routing, reviews, escalation & approvals.

Powerful dynamic searching of documents for easy access.

Use risk management as a tool throughout design and development, not as an afterthought.

Avoid costly rework and avoidable patient hazards by identifying, mitigating and preventing potential risks earlier in your development process.

Ensure compliance with government regulations and industry standards such as 21 CFR Part 820 and ISO 14971:2012.

Use risk management as a tool throughout design and development, not as an afterthought.

Avoid costly rework and avoidable patient hazards by identifying, mitigating and preventing potential risks earlier in your development process.

Ensure compliance with government regulations and industry standards such as 21 CFR Part 820 and ISO 14971:2012.

Maintain nonconformance records digitally.

Apply a risk-based assessment on escalation and priority.

Link NCs directly to your CAPAs.

Link your CAPAs directly to Complaint and Nonconformance data.

A customized workflow to lead you through Assessment, Root Cause Analysis & Action Plan, Implementation, and Effectiveness & Closure.

Maintain records linked directly to your product versions.

Triage and track your complaints.

Provide a user-facing form to capture complaints from your users.

Automatically generate adverse event reports and send digital copies to FDA as required by 21 CFR 803.