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Enzyme

Intelligent QMS

The smartest Quality Management System (QMS) for Life Sciences. Automate FDA compliance, streamline regulatory submissions, and accelerate time-to-market.

See How It Works ↗

About This Tool

Enzyme is an intelligent platform designed for medical device and biotech companies. It transforms the complex, paper-heavy process of FDA/ISO compliance into a digital, automated workflow. It acts as a “regulatory co-pilot,” ensuring every document, design change, and training record is traceable and audit-ready.

How to Use

  1. 1. Set up your Design Controls directly in the platform.
  2. 2. Link requirements to risks and tests (Traceability Matrix).
  3. 3. Manage employee training and electronic signatures.
  4. 4. Use the “Submission Builder” to auto-compile FDA 510(k) packages.
  5. 5. Monitor your compliance health via the real-time dashboard.

Key Features

📋 FDA 510(k) Gen
🔗 Auto Traceability
🖋️ eSignatures

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Additional Information

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Use Cases

Enzyme is essential for startups and enterprise Life Science companies bringing Class I, II, and III medical devices to market. It replaces disparate systems (Dropbox, Excel, paper) with a single source of truth for all regulatory data.

Automated Traceability

One of the biggest headaches in compliance is maintaining the “Traceability Matrix.” Enzyme’s algorithms automatically link your User Needs -> Design Inputs -> Design Outputs -> Verification Tests. If you change one requirement, it flags all downstream dependencies that need re-testing.

Regulatory Submission

Enzyme allows you to generate a submission-ready PDF export for FDA 510(k) or De Novo applications. The system ensures that all required documents are present, signed, and version-controlled before you submit to the government.

Limitations

This is a specialized B2B tool for the regulated life sciences industry. It is not a general-purpose project management tool and follows strict workflows (21 CFR Part 11) that might feel rigid to non-regulated industries.

Compliance

The platform helps companies adhere to ISO 13485, ISO 14971, and FDA 21 CFR Part 820. It automatically handles version control and audit logs, ensuring that if an auditor visits, you can pull up any record instantly.