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Fractional QA Strategy. Full-System Results.
Fractional QA Strategy. Full-System Results.
Choose from focused 90-day consulting tracks designed for speed, clarity, and compliance impact.
Startup QMS Foundation
Startup QMS Foundation
For: MedTech startups (Seed to Series B) preparing for 510(k), MDR, or audit
What We Do:
Strategic and Flexible Design and Implementation of ISO 13485-compliant QMS from scratch with embedded ISO 14971 Risk Management
Implement QMS subsystems: Design Controls/Risk Management, Document Control, CAPA/Complaints, Production & Process/Supplier Controls and Management Controls
Train internal teams to own and scale compliance post-engagement and emerging standards expert guidance
Acquisition QA Strategy & Integration
Acquisition QA Strategy & Integration
For: PE firms, strategic buyers, or corp dev teams integrating new MedTech assets
What We Do:
QA due diligence assessments pre-close
Post-acquisition QA audits, harmonization and integration roadmaps
SOP alignment, risk prioritization, and team/org restructure guidance
Pre & Post-Acquisition Remediation Lead
Pre & Post-Acquisition Remediation Lead
For: Target, Portfolio or acquired companies needing urgent compliance recovery
What We Do:
Identify and triage DHF, CAPA, complaint handling, and audit risks
Lead strategic execution sprints to resolve top priorities
Serve as interim Quality leader to stabilize systems
Train on QMS, Design Control/Risk Management or emerging standards for compliance improvement foundation
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