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By Yadnyesh Patel, microbiology subject matter expert | Sterility assurance is a critical aspect of the production of drugs and medical devices. This article covers the fundamentals, including the key components of an effective sterility assurance program. |
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By Jim Kasic, Boulder iQ | Under the 510(k) pathway, a medical device manufacturer submits a premarket notification to the FDA. What can you do when the agency rejects your 510(k) or requests more information? |
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By Randy Horton, Orthogonal | The FDA’s Predetermined Change Control Plans (PCCPs) tool aims to ease the regulatory burden of updating AI/ML algorithms. |
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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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