Medical Device companies trust SE-Training with Systems Engineering
Case Study – IVD Class 1 device
- Delivered highly complex hardware and software system development.
- Led System requirements negotiation with Customer:
– Proposed and agreed many modifications to System Requirements
– Derived sub-system requirements
– Configured requirements in Polarion
- Derived Operational, Functional and Logical System Architectures.
- Established Interface Control Documents for critical external interfaces.
- Established ISO 13485 compliant Systems Engineering project framework.
- Modeled system throughput, enabling design optimisations.
- Performed System reliability modeling and analysis, included FMEAs and Reliability Block Diagrams.
- Established System reliability growth strategy and product risk process.
Case Study – Class 2b Medical device
SE-Training were requested to support company whose fielded medical device had serious reliability issues.
- Delivered system reliability analysis including critical analysis of hardware and software design.
- Following successful relaunch of product, continued to support projects and continuous improvement initiatives.
- Improved requirements engineering and systems architecting processes & methods.
- Led selection of MBSE tool.
- Established systems engineering organisational capability framework.
- Provided improvements to implementation of development processes.
- Coached and taught systems engineering methods and processes to engineers and management.