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James Olson replied to the topic "Who Should Be Responsible for Quality: Engineers or Dedicated QA/QC Teams?" – 2 weeks, 2 days ago
@jfm23 I agree that QC/QA should be an independent body, specifically to ensure a QC/QA professional is always in the building. However, as @31623940 touched on, the responsibilities of QC/QA should not only fall on that body. I would consider… Read more»
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enzo.1216 replied to the topic "Why Product Claims Matter in Medical Device Regulation" – 3 weeks, 1 day ago
@31623940 I totally agree. I also wanted to add that I don’t necessarily think involving regulatory professionals early in the process would unnecessarily slow down development. There may be situations where their involvement does add more time, especially if the… Read more»