How We Work

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Quality Commercial Consultants (QCC) helps software-enabled medical device and SaMD teams produce reviewer-ready regulatory and compliance documentation—without disrupting how your organization already builds products. Our work is practical, evidence-driven, and structured for clarity, traceability, and efficient review.

Our Differentiators

We speak SaMD.
Decades in software-enabled medical devices means we understand how engineering, product, quality, and regulatory teams actually work—and how to turn real-world artifacts into reviewer-ready evidence.

No “compliance-in-a-box.”
We don’t drop a prefab framework on your team and call it “transformation.” We tailor the work to your device, your claims, your risks, and your current development reality—so the output is usable, defensible, and built to get you through review.

No new tools (unless we absolutely must).
We work inside what you already use. If someone’s “solution” starts with migrating your tools, it’s probably not a solution. If we recommend a new tool, it’s because there’s a clear compliance reason—and we’ll keep it minimal and targeted.

What You Can Expect

Clear deliverables, scoped to your regulatory need and timeline.
A focused approach that prioritizes reviewer usability and traceability over volume.
Collaboration that fits your environment (your tools, your templates, your cadence).
Direct communication, predictable review cycles, and practical next steps.

Engagement Models

Project-Based (Defined Deliverables)

Best when you have a clear objective (e.g., a submission package, an AI response, audit prep).

Advisory Support

Best when you need ongoing regulatory guidance while your team builds and documents in parallel.

Deadline Sprint

Best when you have a near-term milestone and need focused help fast (submission push, AI response window, audit finding response).

Our Process

Discovery & Fit

We start with a working session to understand your device, intended use, regulatory pathway, timeline, and current state of documentation. We identify gaps, confirm what “done” looks like for your specific context, and align on priorities.

Plan & Scope

We propose a practical plan that defines deliverables, milestones, and what your team provides vs. what we produce. Scope stays tied to regulatory outcomes—submission readiness, audit readiness, or a specific response requirement.

Evidence & Documentation Build

We work from your existing artifacts and build submission-ready documentation that is clear, consistent, and traceable. This often includes:

Organizing narratives so reviewers can quickly understand claims and rationale.
Mapping risks, controls, and test evidence to the required submission sections.
Packaging supporting artifacts so they’re easy to review and defend.

Review-Ready Packaging

Before anything goes out the door, we perform a consistency and traceability pass across the package. The goal is to reduce preventable questions by ensuring the story, evidence, and structure align.

Submission / Audit / AI Support

If you’re in an active FDA review cycle or preparing for an audit, we help you respond efficiently and accurately. That includes preparing drafts, organizing evidence, and tightening traceability so responses are complete and reviewer-friendly.

Closeout & Hand-Off

At the end of the engagement, you leave with a clean, organized set of deliverables your team can maintain—plus clear recommendations for what to do next (without forcing operational change).