Requirements
  • Overall Requirements Management
  • Business Requirements Analysis
  • User Interviews & Focus Groups
  • Questionnaires & Surveys
  • Competitive Benchmarking Analysis
Concept
  • Concept Development & Coordination
  • Diagramming (UML) & Documentation
  • Brainstorming Sessions & Background Research
  • Concept Prototypes & Feasibility Testing
  • Pugh Decision (Pugh) Matrices
Design
  • Photoshop & Creative
  • Design Drawings & Documentaion (SolidWorks)
  • Data Structure & Flow Design & Schema (ERD)
  • API Interfaces Specifications
  • Detail Use Cases & Workflows (BDD/UML)
Development
  • Behavior Driven Design/Development (BDD)
  • Agile & Risk Driven Management
  • Failure Modes & Effects Analysis (FMEA)
  • Database Tracking
  • Assembly Procedures
  • Device Master Records
  • Design History Files
  • Embedded Control Code Implementation
  • Production IT & ERD
  • Lean/Kaizen & Six Sigma Techniques
Optimization
  • Critical Parameter Analysis
  • Tolerance and Stack-Up Analysis
  • System Specification Development
  • Module Specification Development
  • Requirements Traceability Analysis
  • Detail System Design
  • Detail Mechanical Assembly
  • Detail Component Design
  • Embedded Control Architecture & Components
  • Embedded Control Code Optimization
Verification, Validation
  • Test Planning, Protocols, Execution & Reports
  • Six Sigma Techniques
  • Statistical & Analysis
  • Design of Experiments (DOE)
  • Instrumentation & Test Stand Development
  • Test Execution & Automation
  • User & Pre-Clinical (Medical Device) Validations
  • Compliance & Safety Testing/Reporting
  • Reliability Test and Growth Programs
  • Machine Learning & Analytics
Continuous Improvement & Support
  • Lean/Kaizen Techniques
  • Production Drawings and Procedures
  • Process Documentation & Validation
  • User and Employee Training
  • Structured Problem Solving & Six Sigma
  • Continuous Improvement Programs
  • Device Master Records & Design History Files
  • Knowledge Base & Issue Tracking Tools
Regulatory & Quality Systems
  • Quality Systems Development
  • ISO 13485
  • Audit Preparation (ISO/FDA)
  • Design History/Technical File Preparation
  • Submission Preparation & Writing
  • Quality System Regulations
  • Medical Device Directive
  • Corrective & Preventive Actions (CAPAs)
Project Management & Tools
  • Project Management Tools
  • SDLC & Waterfall
  • Agile (Kanban/Scrum, Jira)
  • Requirements Tracking & Traceability
  • Quality System Tracking
  • Training Simulations
  • Verification & Validation Packages
  • Compliance/Clearance Submission & Audit Support
Innovative, Patented & Regulatory-Cleared Products
  • See our portfolio for project examples and recognitions.
  • See about us bios for specific project contributions.
Award Winning Products & Experience
  • Click here to see our award winning portfolio.
  • Contact us for more information and discuss your project.