ISO 14971 2007 MEDICAL DEVICE
RISK MANAGEMENT OVERVIEW
Since ISO 14971 introduces its risk management
in sections 3 to 9, the following material begins with section 3.
3. Establish your risk management framework
Part 3 of ISO 14971 introduces the standard
and discusses general
requirements. These general requirements are
greater detail in Parts 4 to 9. It asks you to establish
that you can use to manage and control the
your organization’s medical devices.
Part 3 also asks you to assign responsibility
for risk management
and to ensure that all risk management personnel
are competent. In
addition, it asks you to define a policy that
governs and controls how
risk acceptability criteria are established
and then asks you to use this
policy to establish risk acceptability
criteria for each medical device.
Finally, it asks you to establish a
risk management plan and to
risk management file for each
4. Perform a risk analysis for each medical
Part 4 expects you to use your risk
management file to document
intended use of your medical device
and to identify the product
characteristics that could affect safety.
It then expects you to carry
risk analysis for each medical
device by identifying hazards
and by estimating the risk for each
5. Evaluate risk for each identified
Part 5 then wants you to
for each hazardous situation.
It wants you to use your risk
acceptability criteria to decide if risk
reduction is required.
6. Develop risk control measures when
risk must be reduced
Part 6 then expects you to identify
control measures that can reduce
your risk to an acceptable level
and then to implement these measures
and to verify that they were in
fact implemented. Once you’ve done this,
Part 6 wants you to use your
risk acceptability criteria to evaluate
whether or not your
risk is acceptable.
Whenever your residual risk is
unacceptable and further risk control is
wants you to determine
whether or not the medical benefits
outweigh the residual risk (it wants you to do a
Part 6 also wants you to review your
risk control measures to see if they
inadvertently introduce new
hazards. It wants you to make sure that all
hazards and all
identified hazardous situations have been considered.
7. Evaluate the overall residual risk
posed by each device
Now that you’ve implemented and
verified all risk control measures,
Part 7 expects you to evaluate
the acceptability of your medical device’s
overall residual risk. If your overall residual risk is
unacceptable, Part 7
expects you to use evidence to decide
whether or not the medical benefits
actually outweigh the overall residual
risks. If your overall residual risk is
unacceptable and if your
overall residual risk outweighs the medical
benefits, then your
medical device is not ready for the marketplace.
8. Review risk management process and
Part 8 asks you to carry out a risk
management review and to
prepare a risk management report before you
release your medical
device for commercial distribution. Part 8
wants you to review your risk
management plan, your overall residual
risk, and both your production
gathering methods and plans.
9. Monitor device during production and
Lastly, Part 9 wants you to establish a
system that you can use to
monitor your medical devices during
production and post-production
phases. It then wants you to use your
system to monitor your own
devices and all similar devices.
Also check out our more
detailed version of ISO 14971.
This page summarizes the ISO
standard. It highlights
the main points. It
does not present detail. To get the
plain English standard, please consider purchasing our
Title 48: ISO 14971 2007 Translated into Plain English.
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that is clear, precise, and easy to understand.
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Updated on March 20, 2013.
First published on February 28, 2011.
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