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Customer Letter/Notification - Is it a field action?

E

eyalhend

#1
Hello all,
As part of my regulatory role, I'm asked to approve a letter addressed to costumers using a given medical devices manufactured by my company.
Generally speaking, the content of the letter guides the customer how to handle a technical issue (falling cover) which is found in batches released for sale.

What is not mentioned is that if this cover is not placed properly, the performance of the system may, in certain circumstances, be out of spec.

Accordingly, is such letter notification resembles a Field action?
Would appreciate your advise.
Thanks!
 
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E

eyalhend

#4
Risk assessment was performed.
The letter intention is to address customers to approach service for any defect found with the covers
 

shimonv

Trusted Information Resource
#5
I see.. so you want to present it as a call to awareness for routine servicing / normal ware and tear.

From an auditing prospective you need to make sure that the risk assessment is in alignment with actual reports from the field and that there are no MDRs related to the cover. Obviously something triggered this customer letter and you need to understand what it is and that the paper trail is in order.

Goodluck,
Shimon
 
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