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  1. 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…
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    4 Sep
  2. 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…
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    6 Aug
  3. 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…
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    22 Jul
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