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This message was posted by a user wishing to remain anonymous Hello Anon, I'm assuming, you're suggesting me, there's no need to add in GUDID now as Enforcement date was extended to 2022-12-08. Please clarify Thanks

This message was posted by a user wishing to remain anonymous Hello Richard, Thanks for your valuable feedback! I'm bit confused now, I should post it to GUDID or not as Enforcement date was extended to 2022-12-08. What could be the circumstances/effects if we don't do? Thanks

This message was posted by a user wishing to remain anonymous Hello, As per ISO 13485, 7.5.6, The organization shall document procedures for the validation of the application of computer software used in production and service provision. Such software applications shall be validated prior to ...

This message was posted by a user wishing to remain anonymous Hello D Michelle, Thanks for your response but do you think, if it's make sense if I ask my SCM team to add those suppliers who provides cleaning services How about, who provide off the shelf items such as Home depot, How about, who provide ...

This message was posted by a user wishing to remain anonymous "Novel devices include those brought to market through the premarket approval (PMA), humanitarian device exemption (HDE), and De Novo pathways, as well as a subset of those that are brought to market with 510(k) clearance or Emergency Use ...