Device Specialists - Medical Device Engineering Services

By: Device Specialists  09-12-2011
Keywords: Project Management

  • Concept Brainstorming & Development
  • CAD & Drafting services
  • Prototyping
  • Component Sourcing
  • Specifications (Components & Assemblies)
  • Verification Testing & Reports
  • Packaging Design & Validation
  • IP Research
  • Project Management
  • Documentation
    • Technical Reports
    • Regulatory Submission Documents (510K, PMA, IDE, CE, Etc.)
  • Quality System (Auditing, SOP Revision, Systems Implementation, Training)
  • Design Validation
  • Design Reviews
  • Risk Analysis
  • Design FMEA
  • Manufacturing
    • Transfer Process
    • Manufacturing Procedures & Training
    • Tool & Fixture Design
    • Equipment IQ OQ PQ
  • Validation Master PLan Development
  • Project Management
  • Factory and Site Acceptance Testing (FAT, SAT)
  • Start-Up and Commisioning
  • Installation, Opperational, and Performance Qualification
  • Protocol Execution
  • Summary & Final Report Development
  • Standard Operating Procedures (SOP) Development
  • Quality Audits
  • Gap Analysis

Keywords: Project Management