ProRelix Research Is The Best Clinical Research Organization That Delivers Services like Clinical Development, Design Study, Patient Selection, Project Management, And Project Study In Clinical Research. Our organization helps to conduct clinical trials in phases 1 to 4 along with accurate data management.

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PMS Process and Risk
Management Plan: what is it?

2. The PMS process is focused on the collection and analysis
of the data that comes from the various sources and is
carried out according to a PMS plan to be established for
each MD in order to:
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Update the benefit-risk determination and
improve the risk management;
Update the design and manufacturing
information, the instructions for use and
the labelling;
Update the clinical evaluation;
Update the summary of safety and clinical
performance;
PMS Plan For Each MD

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Identify the needs for preventive, corrective
or field safety corrective action;
Identify options to improve the usability,
performance and safety of the device;
Contribute to the post-market surveillance of
other devices;
Detection and reporting of trends.
Risk management requirements for post-
market surveillance for medical devices.

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With PMS becoming a duty for medical device
manufacturers, the effective risk management system
becomes a priority as well as one of the three basic
elements that ensure compliance and safety, alongside with
PMS and clinical evaluation

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Risk Management Plan

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According to the MDR, manufacturers are expected to provide
evidence of a risk management plan created for the whole
lifecycle of products. Such plans should be used for tracking
and reducing any potential hazards and ensuring the safety
of the devices.

8. ProRelix Research
is here for the
timely execution
of your projects!
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