UDI CONSULTING
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For many companies, expanding or implementing laser marking with the
respective structures and requirements is a process outside of their core
competencies. Especially for the marking of UDI Data Matrix Codes, the due date for
implementation of direct marking of Class II instruments in the US is
approaching quickly and the factor time needed for such projects should not be
underestimated. Adherence to guidelines and processes also needs to be
respected, as - at least in our opinion – auditors will lay special focus on
this in the years to come.
We offer consulting and support services for your UDI project especially
with regards to adherence to guidelines and the given short window of time. Due
to our experience we can e.g. support you as follows:
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Analysis of current
situation
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Decision „make or
buy“
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Cost caluation
models
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Support of equipment purchasing decision
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Time management / project plans
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Validation support
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Support in
finding parameter for laser- and passivation machines
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Support in building codes acc. to GS1 or HIBC
standards
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Implementation of process structures
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Support of adapting quality documentation (acc. to DIN
EN ISO 13485 as well as 14971)
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Worst-case product finding
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Long time tests
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Support for verification acc. to DIN EN ISO 15415 as
wells as AIM / DPM
Are you interested in our services? Please feel free to contact us at
any time.
Tel.: 07461 171541-0
Email: info@addn-solutions.de