Risk analysis is a term often mentioned in relation to risk management and medical devices. The most relevant place for a medical device company to look for an explanation to this term is in the standard ISO 14971, that deals with risk management for medical devices.

This standard states that risk analysis is:
“Systematic use of available information to identify hazards and to estimate the risk.”
This means that risk analysis is the process that aims to identify hazards and consequences of the hazards and risks related to them. Often, however, the word is used to mean risk management documentation, or sometimes the entire risk management process.

Typically, one attempts to determine the following steps in risk analysis:
– Hazards
– Reasonably predictable events or combinations of events
– Hazardous situations, and
– Harm

Risk Analysis


FMEA stands for Failure Mode Effects Analysis and is the denomination of a method that aims to increase the reliability of products or processes (P-FMEA). The method of FMEA is documented in the standard IEC 60812:2006. The term is sometimes used in place of risk analysis or risk management within the medical device industry. It is important to note that the FMEA, as it is known in the literature and in the standard, cannot be said to meet the requirements of risk management found in the Medical Device Directive.

The FMEA is based on how a component can fail and what consequences the failure will lead to for the system as a whole. Since the components are being analysed, the components of the product need to be known, i.e. construction should have progressed quite a bit before it makes sense to start the FMEA.

Let’s use an example. We have constructed a boat that has a propeller. The boat has a seal on the propeller shaft. In the FMEA, we specifically study the seal and try to identify how it may fail, so-called failure modes. A failure mode that we find is “breakage”, i.e. the seal breaks. The purpose of the seal is to prevent water from leaking into the boat, which it will if the seal is broken. The local effect is ingress of water. For the system as a whole, it means that the boat might sink, which may be considered a fairly serious systemic effect on a boat. If the probability is extremely low, we may not do more with this problem, but if the probability is slightly higher, then we may take action, such as e.g. have double seal, make checks or purchase seals with a high safety factor against breakage. All such measures are also suitable in the FMEA.

FMEA is usually documented in a table. For every line you write, you get an RPN number, a Risk Priority Number, that is used to compare risks and indicate which risks should be dealt with first. FMEA typically does not contain a limit between acceptable and unacceptable risk.

Would you like to learn more about Risk Management?

Get instant access to our online Risk Management for Medical Devices and ISO 14971:2019 course right here. In 6 hours, you can learn more about how to develop new medical devices and maintain them in organisations where design control requirements apply. This course is taken by quality assurance, project management, design engineering or those involved in R&D and product development teams.

Peter Sebelius

Peter Sebelius is a highly esteemed trainer, consultant and entrepreneur in the medical device industry. He is a member of the Joint Working Group that is revising the ISO 13485 and ISO 14971 standards.

He has vast ‘hands on’ experience, having developed, amongst other things, a mechanical chest compression device and an ex vivo perfusion machine for lungs. He has received numerous awards including the Great Design Award and the title “This year’s specialist” by Veckans affärer.

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