Day

April 30, 1997
On April 9, 1997, Mr. Mark Tseng and Mr. Emir Galevi of the United States (U.S.) Food and Drug Administration (FDA) conducted a pre-announced inspection of the computer monitor manufacturing facility, Daesun Industrial Co., Ltd., in Kyunggi-Do, South Korea. The FDA inspectors reported several serious deficiencies found in Daesun Industrial Co., Ltd.’s quality control and...
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Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

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