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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 Services

🔧 Pre-Launch QA Audit (Brands)

Launching a consumer product? Independent senior QA review with one-week turnaround.
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🏭 Pre-Launch CM Audit — China

Senior US engineer on the factory floor before tooling commits. One- or two-day on-site audit with 15-page report.
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Post-Launch Services

⚡ Post-Launch CM Audit — China

Shipped already? Independent root-cause investigation at the line. Stop-sale decision support, backer-shareable findings.
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QMS & Compliance Services

📄 QMS Document Review

Off-site QMS document review against the standard you choose. Gap report in one business day. $750 or $2,000 depending on tier.
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🔍 Process Audit

One named process — CAPA, Internal Audit, Design Control — audited against the standard. WIs + records, two-day turnaround, $750.
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📋 ISO Audit Prep

External lead-auditor mock audit and corrective-action plan before your registrar visit.
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🚨 FDA 483 / Warning Letter Response

Time-critical 15-business-day response packages for medical device firms.
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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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Other

✉️ General Inquiries

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For anything outside the service inboxes above.

📍 Location

QESaaS
Atlanta, GA · United States

Send a message

Form submissions route to [email protected] with an automatic confirmation reply back to you. Standard response time is 24–48 business hours.

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, federal-data tooling accelerates the data layer that used to take a junior consultant the most time, and the engineer reviews and leads every finding before delivery. 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.

How does the contact form work?

Submissions route through Formsubmit, a no-code form-handling service. Your message is delivered to [email protected] and you receive an automated confirmation reply at the email address you provided. No data is stored by QESaaS beyond what's required to respond. See Privacy Policy.

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