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MDMEngineering

Systems Engineering

Systems engineering begins and ends with the customer.

Services that can help your team succeed:

Develop and implement processes using best practices for –

Product Development
Requirements Management / Development
Risk Management (compliant with ISO 14971)
Design Controls (QSR Part 820.20)
Usability Engineering (compliant with IEC62366)
Design Verification / Validation
Software Development (compliant with IEC62304)

Provide facilitation and expertise for rapid development of –

Gather, analyze and prioritize user and stakeholder needs
Customer Requirements
Use Cases
System Requirements
System Integration Planning
Hazard Analysis
Failure Mode and Effects Analysis
Use Error Risk Analysis
Safety Assurance Cases

When you need additional resources, we can become part of your team and generate systems engineering deliverables –

User Needs
Customer Requirements
Use Cases
System Requirements
Systems Architecture
System Integration Planning
Fault Tree Analysis
Hazard Analysis
Design Failure Mode and Effects Analysis
Process Failure Mode and Effects Analysis

Safety Assurance Cases
Traceability Matrix
Usability Engineering Plan / Report
Use Error Risk Analysis
Usability Protocol development and execution
System verification planning, protocols, and execution
System validation planning, protocols, and execution
Software validation
Develop Requirements Management tool schema

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