The medical device sector must meet stringent regulatory requirements plus convince potential customers that they make reliable, safe products. Having a strong commitment to quality can help customers ...
This article covers how the new ISO 13485 standard 1 affects risk management for suppliers. The 2016 revision to ISO 13485 may have profound implications for the medical device industry. The updated ...
The Food and Drug Administration (FDA) issued a Final Rule to amend device current good manufacturing practices (CGMP) requirements of the Quality System (QS) regulation to harmonize the requirements ...
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