EIC Services

The EIC team is dedicated to efficiently assisting clients at any point along the product life cycle.   Below is a phased based guide to areas that EIC can assist clients.

Stage 1

OPPORTUNITY ASSESSMENT

• Research unmet customer needs or undeserved opportunities
• Market Opportunity Assessment- Competitive Analysis, reimbursement
• Product concept brain storm sessions- IP Assistance
• Project Planning and Estimates- ROI, NPV

Stage 2

PRODUCT DEVELOPMENT

• Product Requirements
• Design Specifications
• Design Qualification; Engineering Builds
• Risk Analysis
• Design Verification
• Design Reviews
• Manufacturing Plan
• Pilot Manufacturing

Stage 3

DESIGN TRANSFER

• Process Validation
• Supplier Qualification
• Process Risk Analysis
• Clinical Plan; Design Validation

Stage 4

COMMERCIAL RELEASE

• Regulatory Clearance to Market
• Sales, Customer Service Training
• Execution of Distribution Channels

Stage 5

POST MARKET SURVEILLANCE

• Post Launch Customer Surveys and Interviews
• Distributor Surveys and Follow Up Training
• Schedule Review of Complaints, MDRs, CAPAs, Risk File
• Review ECO/DRC changes to Assure Risks Reduced as Far as Possible

PRODUCT LIFE

CONTINUES IMPROVEMENT

• DESIGN IMPROVEMENTS
• QUALITY AND YIELD IMPROVEMENTS
• PROCESS REFINEMENT
• REGULATORY REMEDIATION