Nortech Medical Solutions Lifecycle Management Services
Flexible solutions at each stage of the product lifecycle
Nortech Medical Solutions utilizes a nine stage phased product development process as the basis for most medical device development efforts. We follow this approach as a “best practice” guide for project planning, while recognizing that each project is different and may require a customized approach. These Development Phases and their relationship to Risk Management, Manufacturing and Verification and Validation are critical and planned accordingly.
1) Initial Idea
- Idea Assessment
- Market Analysis
- Competitive Overview
- Regulatory Assessment
- Business Viabilit
2) Research & Insights
- Needs Analysis
- Voice of the Customer
- Technology Assessment
- User Requirements
- Intellectual Property
- Materials Assessment
- Healthcare Economics
- Pricing Optimization
3) Ideation & Concept Development
- Inputs Definition
- Preliminary Requirements
- Concept Development
- Prototype Development
- Industrial Design
- Concept Evaluation
- Early Biocompatibility
4) Plan & Prepare
- Requirements, RA & Standards
- Product Architecture: Electrical, Software & Mechanical
- Regulatory Strategy
- Clinical Plan
- Risk Management Plan
- Manufacturing Strategy
- Launch & Market Adoption Plan
5) Design & Development
- Detailed Specifications
- Detailed Design
- Mechanical Models
- Electrical Schematics
- Software Code
- Packaging Design
- Bill of Materials (BOM) + Cost of Goods Sold (COGS)
- Risk Assessment
- Test Plans
6) Test & Optimize
- Verification
- Biocompatibility
- Sterilization
- Software validation
- Supply chain
- Device Master Record (DMR)
- Manufacturing Pilot Line
- Process Failure Mode Effects Analysis (FMEA)
- Shelf Life
- Packaging & Shipping
- Regulatory Submission
7) Validate
- System Validation
- Product Training
- Final Instructions for Use (IFU)
- Service Plan
- Trace DIs & DOs
- Risk Mgmt Report
- Close Device History Record (DHR)
- Manufacturing Validation & Verification
- Clinical Studies Support
- Manufacturing Ramp Plan
8) Manufacturing
- Device Manufacturing
- Device Master Record (DMR) Management
- Throughput Optimization
- Supplier Assessment & Management
- High Volume Transfer
- Cost of Goods Sold Optimization
- Class 7 Clean Room
9) Product Lifecycle Management
- Repair Services
- Software Upgrades
- Order Fulfillment
- Service Support
- Product Family Management
- Design & Development Updates
- Continuous Improvement