FDA Compliance made simple

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.

Document Control

  • 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.

Risk Management

  • 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.

Training

  • 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.

Nonconformance

  • Maintain nonconformance records digitally
  • Apply a risk-based assessment on escalation and priority.
  • Link NCs directly to your CAPAs

CAPA

  • 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

Complaints

  • 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

Regulatory Submissions

  • Work with our trusted team of regulatory experts to write your submissions
Questions?


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