Devicix by Nortech Lifecycle Management Solutions

Flexible solutions at each stage of the product lifecycle

Devicix by Nortech 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 Viability
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2) Research & Insights
  • Needs Analysis
  • Voice of the Customer
  • Technology Assessment
  • User Requirements
  • Intellectual Property
  • Materials Assessment
  • Healthcare Economics
  • Pricing Optimization
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3) Ideation & Concept Development
  • Inputs Definition
  • Preliminary Requirements
  • Concept Development
  • Prototype Development
  • Industrial Design
  • Concept Evaluation
  • Early Biocompatibility
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4) Plan & Prepare
  • Requirements, RA & Standards
  • Product Architecture: Electrical, Software & Mechanical
  • Regulatory Strategy
  • Clinical Plan
  • Risk Management Plan
  • Manufacturing Strategy
  • Launch & Market Adoption Plan
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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
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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
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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
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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
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9) Product Lifecycle Management
  • Repair Services
  • Software Upgrades
  • Order Fulfillment
  • Service Support
  • Product Family Management
  • Design & Development Updates
  • Continuous Improvement
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