R&D Strategy
•Design concept evaluation
•Technology assessment
•Development & testing strategy
•Manufacturing strategy
•Product development process
Program Management
•Work breakdown structure
•Schedule development
•Visual Management
•Monitoring systems
•Project rescue
Quality Management Systems
•QMS assessment & remediation
•ISO 13485 implementation
•SOP development
Risk Management & Design Assurance
•ISO 14971 Implementation
•RMF review
•FMEA / Fault Tree / Hazard Analysis
•Overall risk evaluation
Product Development
•Design input management
•Preclinical research
•Concept realization
•Product design
•Software & App development
•Systems integration and testing
Mergers & Acquisitions Support
•IP review
•Design analysis
•Clinical efficacy review
•Manufacturing capability analysis
•DHF assessment