UDI CONSULTING - add'n solutions

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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:
-          Analysis of current situation
-          Decision „make or buy“
-          Cost caluation models
-          Support of equipment purchasing decision
-          Time management / project plans
-          Validation support
-          Support in finding parameter for laser- and passivation machines
-          Support in building codes acc. to GS1 or HIBC standards
-          Implementation of process structures
-          Support of adapting quality documentation (acc. to DIN EN ISO 13485 as well as 14971)
-          Worst-case product finding
-          Long time tests
-          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

© 2018 Copyright add'n solutions GmbH & Co. KG

add'n solutions GmbH & Co. KG
Föhrenstrasse 7
78532 Tuttlingen


Phone: 07461 171541-0
Fax: 07461-171541-1

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