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What is the FDA Q-Submission program?
In the simplest of terms, the FDA’s Q-Submission (Q-Sub) program is a voluntary process in which sponsors or submitters can…
4 Sep
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Understanding the Japanese medical device approval process
Home to several medical device companies, the Japanese market is one of the largest in the world. But despite the…
6 Aug
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Brian Ludovico Q&A: NSF executive director on the benefits of joining MDSAP
The Medical Device Single Audit Program (MDSAP) was introduced in 2014 for a three-year pilot program to allow a single…
22 Jul
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