Product Design
Reliability
Reliability Engineering, Risk & Productivity
The FDA and other regulatory agencies do not regulate “reliability engineering” or “productivity” as standalone disciplines.
Instead, they expect evidence that devices are reliable, risks are controlled, and processes are effective—and they enforce this through design controls, risk management, CAPA, and production controls.
Reliability Engineering
“Can you demonstrate, with objective evidence, that your device will perform safely and effectively over its intended life?”
- Accelerated Life Testing (ALT)
- Weibull & reliability growth modeling
- Design for Reliability (DfR)
- Field failure & complaint trend analysis
Risk Management
“Do you understand your risks, control them effectively, and keep risk files alive after launch?”
- ISO 14971 risk files
- Risk-based design controls
- Post-market risk assessment
- FDA response support (483 / Warning Letters)
Productivity & Operational Excellence
“Are your processes stable, controlled, and capable of producing conforming products consistently?”
- CAPA reduction & effectiveness
- Yield improvement & scrap reduction
- Supplier risk reduction
- Reliability-driven cost reduction
E&E Medicals and Consulting will help you conduct design reviews to identify any major issues that could impede compliance testing.
Test Plan Development
To set reliability goals for your product, and make sure it meets that design at the prototype phase, our reliability experts design a test plan for you that ensures your design will last to your expectations in the real world.
Our test plan has two objectives:
MTBF Analysis
MTBF, or “Mean Time Between Failures” is the average time between failures of a system, and is often considered the “useful life” of the device. The MTBF calculation is done on IT equipment, medical equipment, and Test / Measurement equipment and is most appropriate for electronic systems without any external moving parts.
E & E Medicals and Consulting will apply Life Data Analysis to help you achieve the following:
