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QA & Regulatory Strategy for MedTech Growth
QA & Regulatory Strategy for MedTech Growth
Fractional expertise for startups, investors, and acquirers needing audit-ready systems, risk mitigation, and rapid compliance execution.
Build or fix your quality infrastructure in 90 days or less. No full-time hire required.
Who We Help
Startups
Startups
Preparation and Readiness
Preparation and Readiness
Preparation for FDA/CE submission; FDA, Notified body audits or investor due diligence review readiness; Flexible QMS implementation
PE/VC Firms
PE/VC Firms
Risk and Remediation
Risk and Remediation
Execute QA Risk Assessments, SME Expertise and post-close remediation strategy and execution roadmap, QMS strategic consulting
MedTech/Pharma Acquirers
MedTech/Pharma Acquirers
Due Diligence & Integration
Due Diligence & Integration
Pre-Acquisition due diligence leadership or support and QMS integration post acquisition and in-flight project transition strategy for value delivery
Why MedDev QE Solutions
With 30+ years leading quality teams at BD, Pfizer, Siemens, and J&J, we bring enterprise-level systems thinking to startups and growth-stage environments. We work fast, plug into your team with minimal ramp-up, and leave you with scalable systems.
Tel. (877)250-5022
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