This week we have been focused on Brexit with the implementation of the  new requirements regarding the responsible person. More information can be found in the guidance from the MHRA which gives some insights for the manufacturers, distributors and EC representative.

The medical device coordination group (MDCG) has published a document describing the type of information required and the format for the UDI database and the CND numbering to use. http://www.salute.gov.it/portale/temi/p2_6.jsp?lingua=italiano&id=328&area=dispositivi-medici&menu=classificazione

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ISO 13485:2016 requires to validate software systems used for production and service provision, for the monitoring and measurement of requirements... should be validated. Why not considering FDA guidance on software validation and the use of GAMP5?

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Online workshops are done via webex or zoom sessions.

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