Hello everyone!
I have a question pertaining to the Instructions for Use for a device compared to electronic 'help' pages/video tutorials.
The product my company manufactures is a PACS software application. I'm currently in the process of writing the Instructions for Use Manuals. However, my superiors have informed me that the IFU won't be posted online for our customers (available in paper by request only). Instead, the software currently has eletronic 'help' pages and video tutorials. The 'help' page correlates with whatever you're viewing on the screen - not a searchable tool.
Is this acceptable to meet FDA and EU (MDD 93/47/EEC) regulations? I thought the entire IFU manual had to be provided.
Please note, the IFU and 'help' pages do not correlate.
Any assistance would be greatly appreciated.
Regards, Tonia
I have a question pertaining to the Instructions for Use for a device compared to electronic 'help' pages/video tutorials.
The product my company manufactures is a PACS software application. I'm currently in the process of writing the Instructions for Use Manuals. However, my superiors have informed me that the IFU won't be posted online for our customers (available in paper by request only). Instead, the software currently has eletronic 'help' pages and video tutorials. The 'help' page correlates with whatever you're viewing on the screen - not a searchable tool.
Is this acceptable to meet FDA and EU (MDD 93/47/EEC) regulations? I thought the entire IFU manual had to be provided.
Please note, the IFU and 'help' pages do not correlate.
Any assistance would be greatly appreciated.
Regards, Tonia