Modification to Medical Device User Manual

P
#1
Hi there,

We?d like to modify the wording of our user manual.


Is that acceptable using a sticker to do that (other than reprinting the whole manual?)?



Do anyone know that (or has a similar experience)?
 
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M

MIREGMGR

#2
Probably there's a situational-detail aspect to this, but my general view would be that user information always can be revised to accomplish a justifiable goal, i.e. improve safety and/or effectiveness or something else for which a rationale exists, as long as the revised information is consistent with the product regulatory clearance, the change is controlled, and the revision-level of the presented information is clearly communicated to users in a manner that assures they understand what revision they should be reading in relation to their device version and clinical situation.
 
P
#3
Thanks for those tips, MIREGMGR.

Given that all modifications are in compliance with regulations, is it acceptable to use sticker to make the modifications? (because the manuals are already printed...)
 
M

MIREGMGR

#4
As a practical matter, I'd think that multiple "stickers" would be required, as content changes likely would be internal and users normally expect to identify the subject system and information rev level from the front cover.

But the logistics aside, and subject to situational issues of which I'm not aware, I'd think that yes, a "sticker" approach could work.
 
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