Overall Residual Risk and Risk Acceptability for Medical Devices

One of the requirements for Risk Management in Medical Devices is after product developers have reduced all individual risks associated with a medical device as far as is reasonably possible, they must establish an overall residual or remaining risk level. This level of overall residual risk must reflect the cumulative effects of the individual risks. This presentation will discuss how to meet this requirement and also how to determine what disclosures of risk need to be made in the instructions for use of the medical device.

• What is Overall Residual Risk?
• How does Overall Residual Risk relate to Residual Risk for each hazard?
• Some companies use a risk rating of ALARP, how does this rating relate to Overall Residual Risk?
• How is Overall Residual Risk reviewed for risk acceptability?
• What information about Overall Residual Risk needs to be disclosed to users? To others?
• How is Overall Residual Risk disclosed?

• Teams responsible for evaluation of designs to determine acceptability of the product prior to release
• Regulatory personnel responsible for approval of product literature and also approval of product for release
• Design personnel responsible for the risk management of medical devices
• Quality personnel responsible for risk management activities
• Quality system auditors

Instructor Profile:
Edwin L Bills, was Industry Co-chair for the AAMI Committee AAMI/QM/WG 04 Application of risk management to medical devices, representing the United States on ISO TC 210 Joint Working Group 1 which developed the ISO 14971 standard. He has served as a Director of Risk Management for major medical device companies. Mr. Bills also presented at a number of conferences on Risk Management topics and has authored articles on the topic as well.