Assurance Delivered for New Generation Electromechanical medical Device

Client leveraged engineering services and software from Prenscia Solutions to create reliability and FMEA models for making failure predictions to help develop robust design and manufacturing controls to improve reliability while simultaneously, validating the embedded software.


The Challenge

Our client, a medical equipment manufacturer, was developing a second-generation product design that had many high speed moving parts.

Previous designs had higher than expected failure rates in the field, and new design features required software modification, improvements, and validation to ensure improvement.

The Solution

Based on design data, reliability and FMEA software models were created for failure rate prediction at component and assembly levels.

The models determined the probability of failure of various functions to ensure they met the expected life. Prenscia Solutions partnered with the client to define software and firmware requirements and mapped them to validation activities and test cases to meet ISO 13485 and ISO 14971 requirements.

The Results

Reliability predictions and trends were validated through field return data from the previous generation products for correlation. Accelerated Life Tests of the product continue to validate the predictions and controls put in place.

The models produced by Prenscia Solutions gave the client superior insights, delivering robust predictions for reduced failure rates and the ability to manage risks related to operations planning, warranty, and business forecasts.

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