Medical Devices / Healthcare

Product Risk Automation

For regulatory and quality teams: auto-generate structured PHA risk outputs to support FDA compliance audit readiness.

Problem

Risk assessments require repetitive extraction and structuring of information across design docs, clinical data, and previous submissions.

Approach

We built an AI workflow that reads source documents, proposes risk statements, and fills in PHA templates for expert review.

Outcome

Regulatory teams keep ownership of decisions while offloading the repetitive document work to AI.

• 60% Faster FDA Submission Preparation
• 40% Lower Risk of Costly Product Rework

Imagine this for your own repetitive work

If you have a similar workflow—repetitive analysis, document prep, or reporting—we can apply the same pattern. Most projects start with a focused proof of concept.

Talk to us about a similar workflow