Verification of the Effectiveness of Risk Management in the Medical Device Industry
The Risk Management standard ISO 14971 has been used in the medical device sector for many years, and offers or suggests many techniques, for evaluating, analysing and reducing risks, but how effective is each of these techniques and at which stage of the life cycle should one choose a given technique. There is now in the medical device sector a much greater emphasis on risk management driven by recent standards updates and the appearance on the EU Medical Device Regulation . The MDR has placed a much greater emphasis on post market surveillance, however post-market surveillance in itself is often a rather long-term activity and many problems may arise long before sufficient metrics can be gathered to identify the issues through a post market approach. ISO 14971:2007  does advocate eight sources of assessing risks and by using a wider set of techniques organisations can gain a better estimate of risk and additionally a more accurate output from the risk management process.
In this paper, we discuss the aspects in which the risk management techniques used in medical device industry could be improved based on what are industries are doing to manage risks and decrease possible failures.
KeywordsFunctional safety Risk management Post-market surveillance Medical Device Regulation
- 1.Regulation (EU) 2017/… of the European parliament and of the Council on medical devices, amending Directive 2001/83/EC, Regulation (EC) No. 178/2002 and Regulation (EC) No. 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EECGoogle Scholar
- 2.ISO 14971:2007 Medical devices - Application of risk management to medical devicesGoogle Scholar
- 3.FDA – Manufacturer and User Facility Device Experience database. www.accessdata.fda.gov
- 4.IEC TR 62380:2004 Reliability data handbook – Universal model for reliability prediction of electronics components, PCBs and equipmentGoogle Scholar
- 5.Siemens SN 29500 Failure rates of componentsGoogle Scholar
- 6.Handbook of Reliability Prediction Procedures for Mechanical Equipment NSWC-11Google Scholar
- 7.IEC 62304:2015 (Ed 1.1) Medical device software – Software life cycle processesGoogle Scholar
- 8.ISO 26262:2018 Road Vehicles - Functional safetyGoogle Scholar
- 9.DO-330/ED-215 Software Tools Qualification ConsiderationsGoogle Scholar