Systems Engineering

We are experienced in both top down and bottom up approaches to systems engineering, as well as considerations of human factors, risk mitigation, clinical and agency requirements.

  • Systems engineering management

  • Human factors

  • Risk analysis and mitigation identification

  • Clinical requirements

  • Agency requirements

  • Needs and opportunities analysis

  • Operational concept development

  • System scoping and requirements definition

  • Architecture design

  • System integration

  • Life cycle planning

  • Change analysis

  • Manufacturing support

  • Apply FDA cybersecurity guidance, UL 2900-2-1, ISO 14971, and ISO/IEC 27001 principles to meet both regulatory and technical requirements for connected and embedded medical systems

 

Case Studies