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ISO 13485:2016 & ISO 9001:2015 Certified

        Medical Technologies

        Risk Assessment and Reliability

        Stress Engineering Services (SES) is a leader in providing practical risk assessment, design for reliability and reliability evaluation.  Our highly experienced engineers and designers, broad-based industry exposure, in-depth knowledge of materials and our co-located test laboratory put SES in a unique position to help clients develop superior products.

        Understanding product risk is necessary to make decisions about how to design a product, establish priority in managing activities and allocate resources to the development effort.  The basis for risk assessment and reliability work is to avoid failures and minimize the cost of those that do occur.  The SES technical staff are experts in these areas.  This expertise comes from a long history of helping clients understand the product failures they experience and providing solutions to prevent future issues.  Because of frequent requests for our assistance with these unfortunate events, we investigate more failed products in one year than most developers see in their entire career.

        Risk assessment is a methodology for quantifying the probability of suffering harm or loss from certain products, procedures or devices.  In other words, this method is useful for identifying what can go wrong.  The SES risk assessment process involves the use of multiple tools and is customized to a specific product or process need. These tools include:

        • Independent design review
        • Failure Modes and Effects Analysis (FMEA or FMECA) for design, process and application
        • Fault Tree Analysis (FTA)
        • Critical component identification
        • Validation testing
        • Reliability Block Diagrams (RBD)
        • Experience and engineering judgment

        Reliability is the overall dependability of a product or device, i.e. for how long will it continue to meet requirements?  There are two constituents to product reliability: 

        Design for Reliability and Reliability Evaluation. Design for reliability is an approach to product development that considers the ultimate reliability (dependability) of a product from its initial design stages.  This involves utilizing a design approach that develops products which are:

        • Simple to assemble
        • Tolerant to variations in manufacturing
        • Made of materials suitable for the long-term loads, sterilization and environmental exposure to which the product will be exposed
        • Able to withstand use / abuse loads
        • Easy to maintain

        With our in-house laboratory and our highly experienced engineering staff, SES is in a unique position to make accurate reliability evaluations.  We leverage decades of experience to develop appropriate test protocols and custom testing apparatus to provide actual data used to make life calculations.  The SES micro-instrumentation experience is second to none and we have the ability to make measurements on surgical tools, medical devices and components in-use.  Our reliability tool kit includes:

        • Accelerated life testing of components and assemblies
        • Material characterization including sterilization effects, long-term storage, environmental degradation, impact and other complex behaviors
        • Failure Modes and Effects Analysis (FMEA or FMECA) for design, process, and application
        • Fault Tree Analysis (FTA)
 critical component identification
        • Validation testing
 quantitative life calculations


        Risk Assessment and Reliability

        Risk Assessment and Reliability