Technology
Development Services
Total Project Support... from Idea to Income Statement
Product Design and Development
SolidWorks® 3D modeling
Stereo lithography prototypes
Design Control
Testing and Validation
Business Development
Market Assessment
Market Surveys
Market Positioning
Partnering
Strategic Fit
Market Forecasts
Technology Assessment
Feasibility Assessment
Critical Assumptions
Prior Art Analysis
Literature search
Patent Validity Assessment
Alternative Technologies Assessment
Competitive Intelligence
Market Assessment
Competition, Identification and Analysis
Public Record Search
Market Share, Price Share, Unit Share Analysis
Decision Analysis
Financial Modeling
Risk Assessment
Financial Requirements
Probability Adjusted Return on Investment
Project Management
Stage-Gate™ Work
Flow Process Maps
Timelines - Microsoft Project
Resource Requirements
Critical Path
Subcontractor management
Regulatory
Affairs
Regulatory Strategy
IDE
Applications
Clinical Trial Supervision
FDA
510(k) Application
FDA
CDRH United States Agent for Medical Devices
EU
Appliciation
Essential requirements
Standards
Development
ASTM F29 Anesthetic and Respiratory Equipment
ISO TC 121
Anesthetic and Respiratory Equipment
Expert Witness
Patent Litigation - Engineering and Design
Product
Liability Assessment - Engineering and Design
Failure Analysis
Risk Assessment
Hazard Analysis
Failure
Mode, Affects, and Criticality
Fault
Tree Assessment
Human Factors / Usability Testing
Human Factors in Design
Ergonomics
Use
Error Prevention and Assessment
Use
Testing, Patient Simulator Validations
SolidWorks® is a registered trademark of
SolidWorks, Inc.
Stage-Gate™ is a trademark of RG
Cooper & Associates Consultants, Inc.
