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Compliance Services (21CFR820.30 cGMP)
Medical Device Design Control • Compliance 
Services (21CFR820.30 cGMP) . Quality System Regulation

Systems Engineering

Systems Engineering   Systems Engineering

Developing complex systems in an optimal fashion requires utilization of a systematic approach to the system engineering efforts. Knowing what tools and techniques are available as well as how and when they should be applied is critical to having an efficient program. Toltec provides system engineering expertise specializing in areas under very strict regulatory controls, conforming with the requirements of the FDA, Military, and NASA. Areas in which Toltec will benefit your system development needs include:

  • Specification Development
  • Embedded Systems
  • Electromechanical Systems
  • Critical System Design Techniques for Safety, Reliability, and Compliance
    » Fault Tree Analysis
    » Failure Mode Effects Analysis
    » Risk Analysis EN60601-1-4 (ISO 14971)
    » Reliability Analysis
  • Decision Making/Design
  • Trade-off Analysis
  • Engineering Tool and Product Selection
  • Design for Standards and Regulatory Compliance
    » Product Design Standards
    » EN/IEC
    » CSA
    » UL
    » MIL
    » FDA guidelines
    » others
       » Compliance
    » FDA regulations
    » ISO regulations
Systems Engineering

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