Compliance Corner: Being MDSAP-Ready Helpful While FDA Foreign Inspections Paused, Expert Says

King & Spalding’s Eric Henry urges manufacturers – particularly ones with facilities outside the US – to be prepared for a virtual audit under the Medical Device Single Audit Program. He explains how.

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A medical device maker’s OUS facilities aren’t out of the inspectional woods just because the US Food and Drug Administration isn’t currently inspecting foreign manufacturing plants because of the COVID-19 pandemic, an industry expert warns.

“Unless your foreign site is only shipping to the United States, it’s quite likely that you’re getting certified as well to a standard like ISO 13485, which … is the...

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