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Training Tools in a Medical Device Environment - Do we need to control?

S

sardonyx

#1
Do we need to control documents which are only training tools such as script (on how to present the product to the customers), training in power point presentation & training manuals for clinical nurse educator (CNE), field service engineers (FSE) and even for customers?

Our company manufactures a medical device and I was wondering if we need to control the training tools, does this something to do with FDA requirements?

Your inputs are much appreciated.

:thanx:
 
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K

kl_ravi

#2
I think this should give you an idea...

Clause 6.2.2 The organisation shall .....
a)
b)
c)
d)
e) Maintain appropriate records of education, training, skills & experience (See clause 4.2.4)
 
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