Biological Evaluation Procedure and Plan

We have developed Mandatory Procedure in line with EN ISO 10993-1 and EN ISO 14971:2007 guidelines.

During the preparation of Medical Device CE Marking Technical File, Biological evaluation  is an integral part  and its conclusion.

Cost of Procedure *:200 USD
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Cost of Biological Evaluation Plan : 400 USD
Document ID :
Revision Number:
Revision Date:

Attention!!! We will be providing the word form of the procedure and templets. According to your needs and suitability the words/sentences must be fine tunes before incorporating in ISO 13485 documents or in the Technical file.