Services
FDA Quality Management System Regulation (QMSR) & ISO 13485 Consulting
FDA Quality Remediation & Optimization
- Lead FDA remediation programs from strategy through execution, including 483 response and warning letter recovery
- Conduct audits & inspections
- Develop and improve quality management systems
- Strengthen CAPA (Corrective and Preventive Action) process and execution
FDA Remediation & Enterprise Strategic Program Leadership
Strategic Program Leadership
- Lead enterprise-wide programs
- Develop strategic project plan, establish governance, and lead execution
- Lead remediation programs and provide experienced contractors
- Provide interim executive leadership, when needed
- Lead implementation of AI Agentics to improve quality and compliance
Medical Device Mergers, Acquisitions & Enterprise Integration Support
Mergers, Acquisitions & Integration
- Perform in depth due diligence
- Develop integration roadmaps
- Lead integration and transition activities
Operational Excellence in FDA-Regulated Medical Device Manufacturing
Operational Excellence Programs
- Design robust systems and processes
- Build quality into all processes
- Lead Lean six-sigma kaizen events
- Lead resolution of supplier quality issues