Quality Systems Architecture · FDA Consulting
12 years of FDA-regulated quality engineering across medical devices, pharma, and combination products. I've written the CAPAs, executed the protocols, survived the audits — and I write the software too.
FDA's CSA final guidance dropped September 2025. QMSR went effective February 2026. Every regulated company is in transition — and most are stuck.
Your CSV SOPs reference guidance that's been superseded. Your quality system was built for the old QSR. Your SaMD team is building without a compliant SDLC. These aren't future problems — auditors are asking about them now.
Full transition from legacy CSV to FDA's Computer Software Assurance framework. Gap analysis, risk-based methodology, SOPs, templates, training, and a pilot assessment.
Sept 2025 final guidance is live. Your auditors will ask about CSA.
For: Quality & Regulatory leaders at device and pharma companies running legacy CSV programs
Compliant software development lifecycle for SaMD/SiMD — safety classification, phase gates, requirements management, traceability, SOUP inventory, and risk integration per ISO 14971.
Agile-compatible per AAMI TIR45. Built to ship, not to slow you down.
For: SaMD/SiMD startups preparing for FDA submission
Full gap analysis against QMSR requirements (21 CFR 820 supplemental + ISO 13485:2016). Remediation plan, updated procedures, and inspection readiness assessment.
QMSR went effective February 2, 2026. The grace period is over.
For: Device companies navigating the QSR → QMSR transition
Part-time quality leadership for early-stage companies. QMS ownership, design controls, CAPA management, supplier qualification, audit readiness, and regulatory interface.
Quality leadership without the $180k+ FTE commitment.
For: Seed to Series A SaMD/SiMD companies
Targeted engagements (Part 11 assessments, CAPA remediation, mock audits, training delivery) also available at $175–225/hr.
Most quality consultants hand you a stack of Word templates and an invoice. I build the systems — procedures, tooling, and software. I write TypeScript and Python. I'm building CSA Workbench, an eQMS purpose-built for SaMD/SiMD, because every quality tool I've used was built by people who've never dispositioned a deviation.
Auto-injectors at PCI Pharma Services for Eli Lilly. Combination products under 21 CFR 4. Class III medical devices. Sterile manufacturing. I've executed protocols at 2 AM, written 483 responses under deadline, and built quality systems from scratch. The consulting comes from the work, not a textbook.
Big consulting firms bill $300–500/hr and staff your project with junior associates who've never seen an FDA inspection. You get me — senior-level expertise, direct communication, no layers, no overhead. Project-based pricing aligned to outcomes, not billable hours.
20-minute call. No pitch deck. Just a conversation about where you are and whether I can help.