Please summarize all global Vigilance issues that fulfil the European Reporting requirements in the following/similar format: Report Competent Details of CAPA Raised Root Cause Status Number Authority Investigation Y/N Details 4. Section 8: Risk Management Please Provide the current Risk Management Plan/Report and most recently completed Risk Analysis, including a signed and dated conclusion regarding residual/remaining risks. If applicable please ensure to include relevant risk analysis for IVD Medical equipment and software. 1. Is Compliance being claimed to EN ISO 14971:2012 Yes No Please indicate which of the Multifunctional team provided the clinical output-i.e. risks associated with the clinical use of the device 2. Please provide the document number of the Risk Analysis Matrix / Risk assessment summary matrix/documents and location within the technical file supplied - 3. Please provide a traceability matrix linking the contraindications, warnings and precautions from Risk Management File to the Instructions For Use and CER 4.
4. Please summarize all global Vigilance issues that fulfil the European Reporting requirements in the following/similar format: Report Number Competent Authority Details of Investigation Root Cause CAPA Raised Y/N Details Status Section 8: Risk Management Please Provide the current Risk Management Plan/Report and most recently completed Risk Analysis, including a signed and dated conclusion regarding residual/remaining risks. If applicable please ensure to include relevant risk analysis for IVD Medical equipment and software. 1. Is Compliance being claimed to EN ISO 14971:2012 Yes No 2. Please indicate which of the Multifunctional team provided the clinical output-i.e. risks associated with the clinical use of the device 3. Please provide the document number of the Risk Analysis Matrix / Risk assessment summary matrix/documents and location within the technical file supplied - 4. Please provide a traceability matrix linking the contraindications, warnings and precautions from Risk Management File to the Instructions For Use and CER