Hello Maria,
From a medical device perspective, there is nothing like that which exists. In the pharmaceutical world, not sure. I am not sure there is a threshold limit used in either industry because products can vary so widely it would be difficult to put a singular number on an annual report for rate limits of quality complaints. Typically this would be calculated or generated within each company based on their product type, intended use, and quite a few many other factors such as benefit/risk profile, product established on the market, etc.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 09-Dec-2021 15:52
From: Maria Pinto
Subject: Market complaint - rate limit
Dear all,
Im trying to find some information, annual report related to usual rate limit for quality complaints. I hear that there is a threshold used in the industrie, <0.99, but I dont know the source of this number. Could you help me with this information please?
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Maria Pinto
Master
Aaslmeer
Netherlands
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