Biological Evaluation Report

£100.00

This document also incorporates several new considerations, including the use of risk-based approaches to determine if biocompatibility testing is needed, chemical assessment recommendations to ensure compliance to ISO 10993-1.

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Description

When assessing device modifications, it should be stated if the modification does result in a change to any direct or indirect tissue-contacting components. Therefore, further biocompatibility information would typically be needed. This document also incorporates several new considerations, including the use of risk-based approaches to determine if biocompatibility testing is needed, chemical assessment recommendations to ensure compliance with ISO 10993-1.

Our templates are developed with consultants who have over 20 years of experience in the Medical Device industry and documentation that has been through successful audits. Our consultants are available, should you need further assistance in completing the documentation.