![]() Are people simply not paying attention to the observations they receive? Are they intentionally not being compliant? Probably not, but then, what are the reasons? Based on FDA data, the same issues are the top issues year after year.In this episode of the Global Medical Device Podcast, Jon Speer talks to Tom Rynkiewicz, Vice President of Life Sciences for RA/QA and ASQ Certified Quality Auditor, about the three most common compliance issues and offer answers to questions like, why are the same select areas continuing to cause issues and what’s beyond these recurring compliance issues? Some highlights of this episode include: As it turns out, there are a few common culprits when it comes to compliance issues for manufacturers. These compliance efforts will be put to the test once an FDA inspection or ISO audit rolls around. Medical device companies must comply with a list of strict requirements throughout the duration of their product's lifecycle.
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