Process validation for medical devices: Why and when it’s required
Process validation is crucial when manufacturing medical devices, especially where the quality and safety of the final product cannot be fully verified without destructive testing.
Process validation is crucial when manufacturing medical devices, especially where the quality and safety of the final product cannot be fully verified without destructive testing.
This article covers the necessary regulations, standards, and guidelines related to process validation of medical devices in the US and the EU.
Take a look at our online Risk Management course on ISO 14971:2019 and online Design Control for Medical Devices course.
These courses are taken by both competent authorities, notified bodies and medical device manufacturers and distributors.
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