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By Yu Zhao, Bridging Consulting | In early December, the FDA issued final guidance on Predetermined Change Control Plans (PCCPs) for AI-enabled device software functions. This article shares the 13 key takeaways, including differences from the draft guidance. |
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| Cultural Audits: What Are They And Why Are They Essential? | Article | B. Braun OEM Division | The medical device industry is familiar with quality audits, but is less familiar with the benefits of having a cultural audit to assess the competence, dedication, and passion that each party brings to the table. |
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