• Medical Device Design and Development Services

  • Expert guidance from initial concept to FDA clearance

    Midwest-based MedTech Launch by Genesis Plastics Welding, an outsourced medical device design and development services provider, strategically overcomes design hurdles and guides clients from initial concept to FDA clearance and commercialization, through: 

    • 30+ years of medical device manufacturing expertise 
    • Industry collaboration
    • Cutting edge innovation
    • Material and component expertise 
    • Clear documentation and processes
    • Risk mitigation 
    • A robust QMS, as well as ISO 13485 certification
  • Our Medical Device Design, Development and Pre-Production Services Include:

    • Design and Engineer Services, including a focus on: 
      • User Experience 
      • Human Factors
    • Project Management 
    • Product Innovation
    • Research & Development
    • Quick Response Prototyping
    • Regulatory, Quality & Compliance 
    • Validation Services
    • Pre-Clinical Testing Coordination
    • Go-To-Market Strategy
    • Design for Manufacturability 
    • Short Run Manufacture
    • Supply Chain Management
    • Device Consulting Services 

    Learn more about our proven MedTech Launch Go-To-Market strategy. It focuses on excellence in design and development through an emphasis on foundational components, documentation and overall sustainable manufacturability. As a comprehensive and collaborative solution provider, a smooth transition through each major design phase is of the utmost importance to our team.