ISO 10993-1:2018 Format to Perform Risk Management Process

#1
Figure B.1 shows a schematic representation of the risk management process for biological evaluation plan.
Is there any format to perform this assessment?
 
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planB

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#2
As long as you catch all elements of ISO 10993-1:2018, there is no specifically required documenting format. The corresponding FDA guidance contains some general documentation recommendations in annexes E and F. You may want to make sure that your biological evaluation plan (BEP) is followed by a biological evaluation report (BER). The latter is typically requested and reviewed during submissions.

HTH,
 
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