QESaaS is the senior-engineer review most consumer-product, medical-device, and litigation teams need before launch — productized into fixed-scope engagements that ship the deliverable in days, not quarters. Practitioner-led. Tooling supports the labor; the engineer carries the verdict.
A productized senior-engineering practice runs on a small surface area, deliberately. Each of the three tracks below carries the same practitioner-led discipline.
Eight fixed-scope, fixed-price services with published deliverable shapes. No discovery phase, no hourly billing, no scope creep.
Open methodology demonstrations so you can see the deliverable shape before you book a scoping call. No signup. No email capture.
Long-form reference material on the regulatory frameworks consumer-product and medical-device founders run into. Educational, not gated.
Every engagement maps to specific frameworks. Below are the standards QESaaS is calibrated for — covering consumer products, medical devices, and quality management systems across U.S. and international regimes.
No signup. No email capture. The point is for you to see how QESaaS thinks before you decide whether to engage.
Three engineer-reviewed sample reports across consumer-product categories — children's electronics with a battery hazard, medical-adjacent device classification, outdoor fire furniture. See the QESaaS deliverable shape before booking the paid audit.
View case studies →Full published methodology behind every Pre-Launch QA Audit. Reviewable in advance of any engagement. Practitioner-led reviewer discipline documented in detail.
Read the methodology →Long-form explainers on FDA device classification, ISO 10993 evidence packaging, Cp/Cpk for non-statisticians, and consultant-pricing benchmarks. Built up over time, free to read.
Browse the library →Each engagement has a published deliverable shape and a fixed turnaround. No discovery phase, no hourly billing, no surprise add-ons after. Grouped by where they fit: pre-launch prevention, post-launch root-cause, and quality-management-system reviews.
A senior independent read on the product and the factory before tooling commits.
Independent senior-engineer review of a consumer product before it ships. Risk-ranked report in seven days.
View details →Senior US engineer on the factory floor at your Chinese CM before tooling commits. Tier classification + federal recall-pattern context.
View details →When shipped units are failing and you need an independent read at the line — not the CM's narrative.
Independent root-cause investigation at the line. Defect-rate quantification, stop-sale decision support, backer-shareable findings PDF.
View details →QMS document reviews, process audits, mock audits, FDA response, and litigation engagements.
Off-site QMS doc review against ISO 9001, 13485, 14001, 45001, or 21 CFR 820. Written gap report in one business day.
View details →One named process audited against the standard. We read the WIs and the records. Findings tagged Major / Minor / OFI.
View details →External lead-auditor mock audit + gap report + corrective-action plan before your registrar visit.
View details →Response document + CAPA plan + indexed evidence package for FDA Form 483 observations or Warning Letters.
View details →Product liability, recall disputes, quality-system matters. Conflict-check required before any case material is shared.
View details →QESaaS is a solo senior practice. No fictional staff, no rotating contractors, no offshore subcontracting. The name on the deliverable is the name doing the work.
Twenty-plus years in product quality engineering across three categories where the cost of getting it wrong varies from ruined-your-Tuesday to ruined-your-life: medical devices, aerospace, and consumer goods.
Past supplier-quality auditor inside Chinese contract manufacturers — the same factories most consumer-product brands use today. Past Director of Quality at Anatomy Supply Partners (US/China medical device sourcing) and Scotsman Ice Systems. Built the entire quality department at a medical-equipment startup from scratch — hiring, agency documentation, supplier scoreboards — later acquired.
Also the builder behind RecallSentry™, a published iOS and Android app that monitors federal recall feeds across CPSC, FDA, USDA, and NHTSA. The same daily-running data pipelines power the adjacency check inside every Pre-Launch QA Audit — and every output that lands in a delivered report is authored by Mark.
Free 30-minute scoping call. If your project fits a productized engagement, you'll get a one-page brief and an invoice. If it doesn't, we'll tell you why before either side commits.