About Us

25+ Years of Expertise in Medical Device Strategy and Compliance

Quality Commercial Consultants (QCC) is a founder-led quality and regulatory consulting practice focused on software-enabled medical devices, SaMD, and health technology organizations operating under real-world regulatory and client audit pressure. We help teams produce clear, traceable compliance evidence that supports efficient review without forcing a “compliance-in-a-box” operating model.

Who We Help

Software-enabled medical device and SaMD sponsors preparing for FDA submissions or responding to Additional Information (AI) requests.
Health technology vendors and suppliers who need audit-ready evidence for regulated healthcare, medical device, or pharma clients.
Teams with strong engineering execution that need regulatory-ready documentation, structure, and traceability.

What We Do

510(k) submission planning, organization, and documentation quality control.
Cybersecurity and AI/ML documentation support packaged for reviewer usability and traceability.
Risk and evidence alignment across claims, labeling, risk analysis, and verification/validation artifacts.
QMS and compliance support for audit readiness, gap identification, and documentation planning.
Supplier and HealthTech compliance evidence packages for diligence, onboarding, and client audits.

How We Work

QCC meets your team where you are. We build on the tools, processes, and artifacts you already have, then translate them into reviewer- and auditor-ready documentation. If additional tooling is warranted, we’ll propose it only when it materially reduces risk or improves outcomes—not as a default.

How QCC Works

Our Results Speak for Themselves

Andy translated complex DOE and DOD requirements into a cybersecurity plan that helped secure a substantial grant from the DOE to build our battery factory in North Carolina. It was a clear and implementable plan ready for diligence review, and he kept our team moving forward without adding unnecessary overhead costs. Michael Kleinberg CFO Forge Nano

About Andy Miller

QCC is led by principal consultant Andy Miller. Andy has worked in regulated industries since 2000, starting in pharmaceutical information systems and progressing into software quality, quality leadership, and regulatory leadership roles supporting novel, cutting-edge software-enabled medical device companies. Since 2015, he has consulted with medical device manufacturers and health technology organizations that must satisfy both regulators and enterprise client compliance programs. He has also supported cybersecurity compliance documentation efforts in other regulated environments, including the Department of Energy and Homeland Security contexts.

If you’re preparing a submission, responding to an AI request, or getting audit-ready, schedule a consultation. We’ll review your timeline, your current artifacts, and the fastest path to clear, defensible documentation.