Reliable Care with Reliable Software

Transforming Healthcare through Reliable Medical Devices

Software reliability services, training, and tools for medical devices and equipment

Ensuring software reliability in medical devices and equipment is a significant focus of our work. FDA-regulated medical devices face unique challenges related to reliability, software failure modes, and effects analysis. Addressing these challenges necessitates the expertise of an analyst well-versed in the industry and its products.

Facilitate and conduct Failure Modes and Effects Analysis (FMEA) for software and firmware design in FDA-regulated medical devices and equipment.
Perform root cause analysis for software or firmware defects to ensure that development, review, and testing efforts are focused on the most prevalent failure modes.
Evaluate the reliability of software and firmware for medical devices and equipment utilizing industry-standard models.
Identify viable alternatives to enhance software reliability in medical devices and equipment.
Review software and firmware development processes to ensure they are optimized for reliability.
Conduct and facilitate software and firmware fault tree analysis, employing a top-down approach that informs both requirements and the software design FMEA.
Offer practical and validated recommendations to improve processes and software, while also enhancing on-time delivery.