Hi Karen, I have been in a similar situation before, as an ISO 13485 certified manufacturer utilizing an ISO 9001 certified contract manufacturer.  Ideally, they would also be ISO 13485, but as you mentioned, most seem to have ISO 9001.   Since the risk of this supplier was high, I created a supplier audit checklist identifying the clauses of ISO ...

This message was posted by a user wishing to remain anonymous Hello, For Class I Stand alone software, UDI requirements are not clear.  They state that Class I devices do not need to include PI, but version for software needs to be shown and this is PI. What do you show on the User Interface (UI)? Do you just show a DI and the version? ...

Hello everyone, I'm seeking some advice on putting together a regulatory strategy.  What are some questions I should be looking for?  If anyone has any guidelines on putting together a regulatory strategy, I'd appreciate it.  Thanks very much. ------------------------------ Karen Zhou ------------------------------

Dear All, I hope you are doing fine, I have been searching for rules to notify post-approval changes in Russia without exit! could anyone help me? Thank you in advance Best Regards ------------------------------ Fabiola Patino Reegulatory Affairs Specialist Mexico ------------------------------

Hi,  Thank you, I see do you know if there is a rule, instructions, regulation or any that could help me to know it? an example could be: "a change in specification of an MD class III, and the stock was imported before the change was implemented" Best regards ------------------------------ Fabiola Patino Pharmaceutical Chemist Noche Buena Mexico ...