Sustaining engineering is the technical support of already existing products.
In particular, the 2 following situations require attention and are usually associated with extra unexpected burden:
New field issues: such as a new technical device malfunction, or a usability issue
Tessier Biomedical Consulting provides support with the following activities:
Failure root cause analysis
Problem characterization with stakeholders
Root cause analysis to identify what, how, and why an event occurred so that steps can be taken to prevent future occurrences.
Based on an extensive experience (for instance with Japanese companies...) Tessier Biomedical Consulting's favorite tools are: Fault tree analysis, 5 whys, cause an effect diagram.
Based on the root cause analysis, Tessier Biomedical Consulting can organize workshops with the design teams to find solution(s) for fixing the problem.
Legacy products usability engineering file
Many manufacturers are interested in applying the usabily engineering tools to user interfaces that have already been commercialized prior to the publication of the IEC 62366-1:2015 standard. Tessier Biomedical Consulting can help managing the situation with a simplified version of the usability process.
Product modification ("design change"): Tessier Biomedical Consulting can help updating the usability engineering file.
Post-production risks analysis update
According to ISO 14971, manufacturers need to monitor production and post-production for data and information that relates to the identification of new hazards and can affect their risk estimates. The risks analysis must then be updated accordingly. Tessier Biomedical Consulting can help you with this process.
You feel interested by any of those services?
Please contact Tessier Biomedical Consulting by email or call +33 6 5881 8544
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