M
Masey B
Hello All,
Our Notified Body has requested we provide a traceability matrix with "detailed verbiage of indications statement, contraindications, warnings and precautions and complications showing traceability across IFUs, Risk Assessments and Clinical Evaluation Report".
We have attempted to provide the information numerous times in different formats but we just cant seem to satisfy our NB.
Does anyone have a template of a traceability matrix for labelling, risk assessments and CER which has been deemed acceptable by their NB which you would be willing to share please?
Many thanks in advance
Masey
Our Notified Body has requested we provide a traceability matrix with "detailed verbiage of indications statement, contraindications, warnings and precautions and complications showing traceability across IFUs, Risk Assessments and Clinical Evaluation Report".
We have attempted to provide the information numerous times in different formats but we just cant seem to satisfy our NB.
Does anyone have a template of a traceability matrix for labelling, risk assessments and CER which has been deemed acceptable by their NB which you would be willing to share please?
Many thanks in advance
Masey