Articles

This illustrated guide will provide a useful overview of risk management and ISO 14971; and address common misconceptions within risk management.

The requirement of having a policy for establishing criteria for risk acceptability was added in the ISO 14971:2019 version of the standard was because the concept was often misunderstood in the previous 2007 version of the standard.

As the final part of this series, this article focuses on categorising risks based on the different life-cycle phases of a medical device in order to efficiently address them to avoid harm. Not all medical device manufacturers segment their documentation into three distinct documents but risk association with life-cycle phases is common in the industry.

Part 2 of this series of three articles investigates the dangers of dividing risk management documentation in general or according to Team NB’s recommendation. By using a heart-lung machine as an example, this article will present a comprehensive approach to risk control measures in medical device risk management.

This first article in a series of three will be discussing the dangers of dividing risk management documentation according to Team NB’s recommendation. When performing risk management according to ISO 14971, a lot of medical device companies split up risk management documentation into “design risk assessment”, “process risk assessment” and “use risk assessment”. Not only is this common practice, but it is also recommended by Team NB.

Performing risk evaluation is perhaps the easiest part of risk management. Yet, it is important to know how to do it properly to perform risk management successfully.

This article explores the Covid-19 situation from a medical device risk management perspective and compares how the risks of Covid-19 would be addressed when applying ISO 14971 risk management compared to what governments have done.