MDR reporting and CAPA thoughts? Classifying Complaints on Risk

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R

regork

#12
Are you looking for thoughts on applying a risk based methodology for deciding if a quality issue (such as complaint) requires the implementation of a corrective action to prevent the issue from recurring? If so, I identify a risk based method such as
Low = estimated risk is low and probability of occurrence is known;
medium = if the estimated risk is moderate or the probability of occurrence is unknown, then a formal CAPA should be considered;
High = if estimated risk is high, or there are multiple cases that require multiple corrective actions, a quality improvement plan may be more appropriate.

In terms of reporting an issue to regulatory authorities (MDR), it is an action required to resolve the device complaint. It may also be followed by a device correction / removal as an action to resolve the issue.

The act of you receiving a facility reported medwatch does not automatically create an action of an MDR or even corrective action. It must be evaluated by the manufacturer to determine if the reporting criteria (of the manufacturer) has been met.

Let me know what you are looking for, would process examples help?
 

tazer

Involved In Discussions
#14
I get into the discussion to make my little contribution regarding the place of risk analysis in this process.
I do not know 13485 very well, and reading Antun I understand that risk management is excluded from this process.
But the 14971 requires some actions as part of the PMS.

To summarize my approach:
The decision to report the event can be taken as a decision tree that deals only with death or serious injury that has occurred or is likely to occur. The answer is Yes or No.

The decision to initiate a CAPA is linked to the evolution of the risk analysis file.
The RMA is updated, if necessary, by the event, either by adding an unidentified risk or by increasing the frequency of risks already identified. If a risk becomes unacceptable through a benefit/risk balance, a product change must be implemented (as part of a CAPA)
 
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