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Engagement inquiries route directly to Mark. Each service has a defined scope and a free scoping call before any invoicing.

🔧 Pre-Launch QA Audit (Brands)

Launching a consumer product? Independent senior QA review with one-week turnaround.
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⚖️ Expert Witness (Litigation Teams)

Quality-system, recall, and product-liability cases. Plaintiff or defense — conflict-check first.
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🚨 FDA 483 / Warning Letter Response

Time-critical 15-business-day response packages for medical device firms.
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📋 ISO 13485 / 9001 Audit Prep

External lead-auditor mock audit and corrective-action plan before your registrar visit.
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✉️ General Inquiries

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For anything outside the service inboxes above.

📍 Location

QESaaS
Atlanta, GA · United States

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FAQs

Frequently Asked Questions

Quick answers about how engagements work before you reach out.

How fast can a Pre-Launch QA Audit be turned around?

One week from kickoff to delivered PDF. The methodology is published in advance and AI handles the data labor that used to take a junior consultant the most time. See the service →

Is there a free initial scoping call?

Yes. Every service includes a free initial scoping call (typically 30 minutes) before any retainer or invoice. If the engagement isn't a fit, you'll hear that on the first call — not after invoicing.

Will you sign an NDA?

Yes. A mutual NDA can be signed before any product documents, design files, or case materials are shared. There's a one-page template available, or your own NDA is fine.

Are you available for plaintiff or defense expert witness work?

Both, subject to conflict check. Once retained for a side in a given case, I will not consult or testify for the opposing side in the same matter. Conflict check happens before any substantive case discussion. See the service →

What's the typical FDA 483 / Warning Letter response timeline?

FDA expects a written response within 15 business days of issuance. The engagement is structured around that deadline: formal response drafting, CAPA plan against each cited observation, and mock-audit before submission. See the service →

How does pricing work?

Pre-Launch QA Audit: Fixed price, published. Expert Witness: Hourly rate against a per-case retainer, terms set after conflict check. FDA 483 Response & ISO Audit Prep: Quoted after a free scoping call once scope is understood. No engagement begins without written scope and a quote in hand.

Are engagement materials kept confidential?

Yes. Engagement materials are not reused for other clients, not published as case studies without written consent, and not retained beyond the period needed to deliver the engagement and meet professional record-keeping obligations. NDA terms govern where signed.