Change Control — Process Package (ISO 13485)
€69.00Change Control SOP with comprehensive Change Form including MDCG 2020-3 substantial change assessment matrix.
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Notified Body Change Notification — Process Package (ISO 13485)
€69.00Notified Body Change Notification SOP with comprehensive NB Change Notification Form per EU MDR Art. 56(2) + MDCG 2020-3 Rev.2.