Verification of the Effectiveness of Risk Management in the Medical Device Industry

Abstract

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 [1]. 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 [2] 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.