Process Validation Requirements: Is Periodic Re-Validation Required in MedTech?

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  • Опубликовано: 29 ноя 2023
  • What is the requirement for periodic re-validation in the medical device industry?
    There is no requirement for periodic re-validation. The continuous monitoring of your process data ensures the ongoing validity of the validation. However, it is important to emphasize that we are only discussing periodic re-validation while recognizing that certain situations may trigger re-validation.
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    #medtech #medicaldevices #medizintechnik #regulatoryaffairs #medicaldevicemanufacturing #qualitycontrol #qualityassurance #medicaltechnology #testmethod #validation
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