Medical Device Literature Translation Software

vardag

Starting to get Involved
#1
Hello All,

Would a medical device literature online translation software having automatic and human translations and combined computer/human translations need Tech Files for ISO 13485 certification?
 
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somashekar

Leader
Admin
#2
Hello All,

Would a medical device literature online translation software having automatic and human translations and combined computer/human translations need Tech Files for ISO 13485 certification?
The standard permits non-applicabality in clauses 6,7 and 8
Since the Tech files (Medical device file) is in clause 4, it applies... But
In your case if you keep all your documents for every job you execute under one file and maintain such file in your document control, you must be fine. Link to applicable documents all under a file for your job will also suffice.
 
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