Software Reliability for Medical Devices
Software reliability for medical devices and equipment is a large part of what we do. FDA-regulated medical equipment and devices have particular challenges with regards to reliable and software failure modes effects analysis. Those challenges require an experienced analyst who knows the industry and the products.
Software reliability services, training and tools for medical devices and equipment
Conduct and facilitate software and firmware design failure modes effects analysis for FDA regulated medical devices and equipment
Conduct a software or firmware defect root cause analysis. This ensures that development, review and test and effort is tailored on the failure modes that are the most prevalent
Assess the software and firmware reliability for medical devices and equipment using industry-accepted models
Identify feasible alternatives for improving the software reliability for medical devices and equipment
Review the processes for developing software and firmware to ensure that they are optimized for reliability
Conduct and facilitate software and firmware fault tree analysis. The software fault tree analysis is a top-down approach that can drive requirements as well as the software design FMEA.
Provide feasible and proven recommendations for improving the processes and the software while also improving on-time delivery
Estimate software and firmware reliability growth using recognized and established models
Provide expert guidance with regards to IEC 62304, ISO 14971, CFR820 and EU MDR
