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Quality System
   Architects
Building Quality Foundations for Future Growth
Call today! (224) 217-1578
CONSULTING SERVICES
"Hands-On Approach" 
  • Quality System Compliance Gap Analysis
  • Project Planning/Management
  • Quality System Development
  • Training
  • Procedure Writing/Review
  • Inspection Readiness
  • FDA Response Assistance
  • Acquisition Integration
  • Organizational Design
  • Culture Change Management
OUTSOURCING
Maximize your Resources and Reduce Expenses
  • Auditing
  • Recall Notification Mailings
  • Complaint Handling
  • Medical Device Reporting
  • Regulatory Intelligence Gathering
  • Due Diligence
PRODUCTS
Provide your Staff 
Quality Tools & Motivation
  • Training Materials
  • Procedure Templates
  • Workbooks
  • Regulatory Intelligence Reports
  • Motivational Merchandise
TURN-KEY SOLUTIONS
Comprehensive Start-to-Finish Packages
  • Enforcement Action Resolution
  • Complaint Handling Unit Development
  • Full Quality System Development 
  • QA/RA Organizational Design
A Division of Wolf Enterprises, LLC  -  West Chester, Ohio 45069