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.
Keywords
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
References
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/EEC
ISO 14971:2007 Medical devices - Application of risk management to medical devices
FDA – Manufacturer and User Facility Device Experience database. www.accessdata.fda.gov
IEC TR 62380:2004 Reliability data handbook – Universal model for reliability prediction of electronics components, PCBs and equipment
Siemens SN 29500 Failure rates of components
Handbook of Reliability Prediction Procedures for Mechanical Equipment NSWC-11
IEC 62304:2015 (Ed 1.1) Medical device software – Software life cycle processes
ISO 26262:2018 Road Vehicles - Functional safety
DO-330/ED-215 Software Tools Qualification Considerations
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2018 Springer Nature Switzerland AG
About this paper
Cite this paper
Riess, A., Lepmets, M., McKechnie, S., Walker, A. (2018). Verification of the Effectiveness of Risk Management in the Medical Device Industry. In: Larrucea, X., Santamaria, I., O'Connor, R., Messnarz, R. (eds) Systems, Software and Services Process Improvement. EuroSPI 2018. Communications in Computer and Information Science, vol 896. Springer, Cham. https://doi.org/10.1007/978-3-319-97925-0_31
Download citation
DOI: https://doi.org/10.1007/978-3-319-97925-0_31
Published:
Publisher Name: Springer, Cham
Print ISBN: 978-3-319-97924-3
Online ISBN: 978-3-319-97925-0
eBook Packages: Computer ScienceComputer Science (R0)