The main automated production line

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Ina medical device plant two consecutive engineering changes were made to the main automated production line bbb on 01. march.2015 and 08.march.2015, to correct a recurring hardware problem in the metal detector which caused false alarms. the testing protocol and results of these engineering changes, including testing under actual conditions, were not documented. on 06. may.2015 a engineer report for the metal detector documented similar false alarm problems and no action was taken.

Is the plant non-conformant with ISO 13485:2016 and 21 CFR 820 documentation ?

Reference no: EM132165872

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The main automated production line : Ina medical device plant two consecutive engineering changes were made to the main automated production line bbb on 01.

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