Medical Device Traceability Matrix - Examples

#1
Hello All,

Our Notified Body has requested we provide a traceability matrix with "detailed verbiage of indications statement, contraindications, warnings and precautions and complications showing traceability across IFUs, Risk Assessments and Clinical Evaluation Report".

We have attempted to provide the information numerous times in different formats but we just cant seem to satisfy our NB.

Does anyone have a template of a traceability matrix for labelling, risk assessments and CER which has been deemed acceptable by their NB which you would be willing to share please?

Many thanks in advance
Masey:thanx:
 
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yodon

Staff member
Super Moderator
#2
Well, I was hoping someone would jump on this and give the perfect answer. Maybe this will get the discussion going at least.

Sounds like a rather strange request / requirement. What, exactly, are they citing as non-compliant?

When we develop anything that defines risk controls, we always tag each control and trace to where implemented. So if we have identified a need to put something in the IFU based on the risk analysis, we tag the requirement and trace that to a test case that demonstrates the IFU does, in fact contain the required information.

Not sure that I've ever heard of any tracing regarding contraindications, warnings, precautions, or complications UNLESS driven by the risk analysis.

Getting into the Clinical Evaluation report, I can't even begin to imagine what they're expecting. Certainly the intent (at least partly) is to confirm that the risk analysis is complete and accurate but I don't know about traceability. I could see a case where the clinical evaluation identifies new risks or other updates needed to the risk analysis but I would think this would be identified through the standard change controls (maybe that helps traceability - referencing the change request opened?).

Again, hopefully others will weigh in.
 
#5
I agree with Yodon, seems a rather strange requirement. Who is your NB? Traceability matrix is well defined in CE mark standard, and what it should contain, and this is not one of the requirements. Risk evaluation should be part of the traceability matrix. Other than that the basic TM should contain:
  • Specification,
  • Version,
  • Risk design assessment,
  • Input,
  • Output,
  • Review,
  • Verification,
  • Validation,
  • Transfer,
  • Changes,
  • Label,
  • Test case/use case.
Plus, a good one should let you add other inputs. In excel that means adding an extra column with specifics related to your device.
The Cross-referencing in a TM is demanding, it takes a lot of time to put together, I know that very well, my boss repeats that ad nauseam how it took him one and half months (probably exaggerated) to put together the traceability matrix for our last FDA submission. He was adamant we would do something different the next time.
 
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#6
I would use a dedicated Traceability tool.

Certainly never try and maintain a manually created traceability matrix.

Use of such a traceability tool does usually require that you have a reasonably well defined development process,
(which I assume you have). It is then possible to configure the tool to automatically match the links between
artifacts created in different tools (i.e. Requirements, Tests, Code etc).

Subsequently generating the traceability matrix, is a trivial task as it is one of the primary use cases of such tools.
 
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Teyla

Starting to get Involved
#7
Hi everyone.
Hope my experience can help. As David A mentioned there a lot of Traceability tools available... We're using the one for organizing the DHF. I wrote about it in another thread. Find it here.
But, the matrix can be built according to the specific needs. So, you can build the required structure.
If you want to have complete overview, the additional columns (inputs) can be added to your DHF one.
 
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