Team

Jim Ward

Consultant

Jim Ward is a highly experienced Medical Device and Combination Product Design and Development professional with a proven track record of successfully delivering new products to market and turning medical innovations into profitable, commercialized products.  Jim specializes in development, regulatory approval, and commercialization of complex medical devices while ensuring effective and efficient development practices and conformance with procedures and regulations.  Jim’s  broad range of development experience includes internal development, outsourced development, manufacturing technologies, and process design, development, and validation.

Academic & Professional Qualifications:
  •  B.S. Mechanical Engineering, University of Oklahoma
Training, Quality Systems, & Specialties:
  • GMP Requirements & Industry Practices
  • FDA Quality System Regulations
  • Design Controls
  • Process Validation,  Design Validation, Design Transfer
  • Stage-Gate Product Development Process
  • Combination Products Regulations
  • Combination Product Design & Development
  • Medical Device Design & Development
  • Global & Multi-site Program Management
  • Design For Manufacturability & Assembly
  • Disposables & Systems Development
  • Low & High Volume Disposable Devices
  • PMA & 510(k)
  • Computer Aided Design