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发布日期:2021年12月07日

Certified

ISO 13485

Leading Contract Manufacturer

of RF Welded Products

  • 720 East Broadway Fortville, IN 46040
  • 317.485.7887

Certified

ISO 13485

Leading Contract Manufacturer

of RF Welded Products

Design and Development Engineering Services

MedTech Launch Design & Development Engineering Services for Go-To-Market Success

MedTech Launch by Genesis Plastics Welding’s design and development engineering services for Go-To-Market success focus on excellence within foundational components such as, product definition, product requirements, key tolerances, proof of concept, documentation, prototyping, quality management, compliance, regulatory support, labeling, packaging, sterilization, validation, regulatory support and overall manufacturability, while overcoming design hurdles and mitigating risks.

MedTech-Launch-Medical-Device-Development

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
Medical Device Clean Room Manufacturing Genesis Plastics Welding

Our Medical Device Design, Development and Pre-Production Services Include:

Genesis Plastics Welding Sales & Engineering Staff
  • 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. 

Evolving MedTech Design and Engineering for Launch Success

medical-device-design-process

Empowering Innovation for Go-To-Market Success

Let’s Discuss Your Project!

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