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UPDATES

This week we have been focused on the implementation of the MDR with the publication of the guidance from the MHRA which gives some insights for the manufacturers and the notified bodies.

The medical device coordination group (MDCG) has published a document describing the type of information required and the format for the UDI database.

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 workshop for sterilization by Ethylene Oxyde is available on 15th October 2019. This workshop includes a presentation of the requirements and how implementing them in practice for compliance with EN ISO 11135.

We are pleased to announce our next online workshop for sterilization by steam is available on 21st October 2019. This workshop includes a presentation of the requirements and how implementing them in practice for compliance with EN ISO 17665.

Online workshops are done via webex.

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