RISK MANAGEMENT REPORT TEMPLATE RISK MANAGEMENT Ref: XX
Rev: 1
Page No 1 of 2
Report Approval (Delete as appropriate) Name
Responsible Author Quality and Compliance Manufacturing Regulatory
Signature
Date
Risk Management Report 1.0 Introduction Scope This document covers the (Device/Product Name) described above and the potential hazards that may be associated with the product. The evaluation covers the patient, operator, service personnel, and the device itself during manufacture, use, servicing, transportation, and storage. The introduction shall address the following points: • •
•
List of the multifunctional team that carried out the FMEA. Indicate that the risk management report is used to demonstrate the requirements of standard BS EN ISO14971: 2007 which have been covered in the FMEA (if applicable). Description of the product
The risk management report shall include product details / comment on the following steps in order to demonstrate compliance to BS EN ISO14971:2007. Purpose The purpose of this analysis is to project what hazards may be encountered by, and through the use of, this device, and provide input to the design team to mitigate the hazards to an acceptable level
2.0 Intended Use/Intended Purpose and Identification of Characteristics Related to the Safety of a Medical Device (4.2 from ISO14971:2007) • •
•
The intended use/intended purpose and indications for use may be gathered from the design input documentation for the product. Additionally, refer to Annex C ISO14971:2007 and list applicable questions from C.2 answering each question relating it to the applicable hazard number in the product and Applicability FMEA’s. Use Appendix 1 of this report as a guide to identify these as Quantitative and Qualitative characteristics.
Report Number – RMXXXX Page 2 of 10
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