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merzkrashed replied to the topic Validation Expiration in the forum Process Validation and Process Risk 7 years, 9 months ago
I think re-validation is required or not depends on the product. So, you need to ask some questions about your medical device, is it something like class I devices, like tongue depressor for example, or it is a class III medical device ?. Validation process cost a lot of money sometimes. However, re-validation might be required, depends on the market changes, or the performance of the medical device.
Re-validation process done every two years for some companies.