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ISO/TL9000/AS9100
Quality Systems

• Gap Analysis & Documentation Review
• Workplan Development
  Project Management
• Documentation Development
• Training & Internal Auditor Development
• Implementation Assistance

Regulatory Assistance

• FDA Establishment Registration
• FDA Device Listing
• U.S. Agent Representation
• 510(k) Submissions, INDs, & NDAs
• Clinical Research & Monitoring
• GMP/GLP/GCP Consultation & Remediation
  Investigational Device Exemptions (IDE)
• Device Pre-Market Approval (PMA)
• Drug Master Files (DMF)

Worldwide Medical
Regulations

• EU Medical Device Directive (MDD)
• US Quality System Regs. (GMP/GLP/GCP)
• Medical Device CE Marketing
• Technical File & Design Dossier Assistance
• EU In Vitro Diagnostic Directive
• Contract Internal Audits
• Quality System (QSR) Training

Business Process
Improvement

• Process Mapping
• Identifying Key Business
  Performance Indicators
• Industry Benchmarking
• Business Process Redesign & Implementation