The Medical Device Regulatory environment is continually changing and our company is perfectly positioned to help you build or rebuild your quality foundation for ongoing compliance, effectiveness and efficiency to facilitate business growth.  We can help you design; we can help you build; we can help you revise or remediate your Quality System.

Invest in Quality Today... 
Prevent Regulatory Enforcement Tomorrow
  • Quality System Compliance Gap Analysis
  • Product and Process Remediation
  • Quality System Development, Implementation and Improvement 
  • Auditing
  • Inspection Preparation and Readiness
  • Regulatory Enforcement Response/Resolution
  • Regulatory Intelligence Gathering
  • Due Diligence/Aquisition Integration
  • Project Planning/Management
  • Organizational Design
  • Culture Change Management
Build a quality roadmap, goals and objectives. 
Develop a plan focused on regulatory compliance, continuous improvement and business growth.

Build a compliant, effective and efficient quality system that is flexible and sustainable over time to complement business growth. Develop a robust monitoring program. 
Build a cohesive, cross-functional team who promote a Quality culture that focuses on on-going product and process quality. Develop a comprehensive training and communications plan.
Strategize
Operationalize
Synergize
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Call today! (224) 217-1578
Partners in Quality 
We believe in assisting our clients with customized quality management solutions for their business through a combination of advisement, hands-on assistance, training, and outsourcing to build a robust quality foundation through strategy, operations and synergy.  Some of the components we offer for your customized solutions package are noted below.
Strategize - Operationalize - Synergize

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A Division of Wolf Enterprises, LLC  -  West Chester, Ohio 45069
Quality System
   Architects
Building Quality Foundations for Future Growth
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