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
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?
We are pleased to announce our next online seminar for sterilization by Ethylene Oxyde is available on 8th June 2020. This workshop includes a presentation of the requirements and how implementing them in practice for compliance with EN ISO 11135.
Your can find HERE the list of our next seminars for 2020 which are all done remotely. If you are interested and would like more information on one or several of our webinars please contact us or register below.
Online workshops are done via webex.