Biological evaluation plan and report

big boss said:

dears can any one share biological evaluation SOPand biological evaluation plan and report template

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Dirk S said:

Hi big boss,
I doubt that a SOP generated by someone else would fit to your specific needs. This depends highly on other processes in your company and should fit with processes as device development, manufacturing, risk management, etc.
I would recommend to consult ISO 10993-1 for content of Biological Evaluation Plan and Report or seek professional support to create such templates. As mentioned before a shared template would probably not be sufficient.

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