Product Development

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Product Development

New products are a great opportunity to create value for customers and grow your business. Medical product development requires a disciplined process to ensure devices are safe and effective for their intended use. L6EP focuses on accelerating development progress by incorporating design control elements throughout the project, which helps ensure user needs are met and risks are mitigated. From initial concepts through market launch, L6EP has the expertise to help achieve your product development goals:

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  • Project Management
    Organizational leadership to coordinate cross-functional support of your product development projects.
  • Engineering Services
    Technical support for product development.
  • CAD models
  • Drafting
  • Machine shop services
  • Prototype development
  • Design Control
    Apply standardized processes to ensure efficient, effective and compliant product development.
  • Design History File 
  • Design Traceability 
  • Risk Management
  • FMEAs 
  • Risk Management Reports
  • Verification and Validation Strategies 
  • Specification development 
  • Usability  
  • Design transfer
  • ePLM 
  • Product Lifecycle Services
    Post-market product and documentation improvements.
  • Sustaining engineering
  • Design for manufacturability
  • Design changes
  • Servicing
  • Device-related complaint management
  • Design History File / Technical Documentation Remediation
  • Testing Strategy
    Ensure compliance with consensus standards and guidance documents.
  • Mechanical Testing
  • Materials Testing
  • Verification and Validation
  • Biocompatibility
  • Sterilization
  • Cleaning Validation
  • Packaging & Labeling Validation
  • Finite element analysis (FEA)