Medical Device Marketing Material - Control of Social Media

margadia

Starting to get Involved
#1
Hi All,

Long time lurker, first time poster. I am the QM for an initial importer/distributor of Class II and III medical devices. We do not manufacture any devices, we work with foreign manufacturers to exclusively sell their devices in the US. We employ a 3rd party distribution warehouse to handle all product, we do not receive in or ship out any devices ourselves. This is a small startup and the QMS is not very robust. I have been developing the QMS but am unsure how to handle document control as it pertains to Marketing material in print or on social media. My main question is, as the importer and not the manufacturer, what are we required to keep track of? We do not produce product labeling as this is all done by the mfr. We do make pamphlets, sell sheets, banners and post on social media about the products. Keeping track of version control for the printed documents is one thing, and I understand controlling what documents we make available on our website but am unsure how social media would play into this. Any feedback would be appreciated!
 
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yodon

Leader
Super Moderator
#2
It's a tough one, indeed. It all boils down to claims. If you say the device is used to treat whatever symptom, that's ok because that's what it's (presumably) cleared for. If you say it's 99.99% effective or it can be used in ways that are outside your cleared indicateions then you have a claim. The whole idea is to not mislead the public.
 

margadia

Starting to get Involved
#3
It's a tough one, indeed. It all boils down to claims. If you say the device is used to treat whatever symptom, that's ok because that's what it's (presumably) cleared for. If you say it's 99.99% effective or it can be used in ways that are outside your cleared indicateions then you have a claim. The whole idea is to not mislead the public.
thanks yodon! that's how we have been treating it. cheers!
 
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