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In Depth: US FDA Medical Device Registration and Compliance
Information current as of January 2017. The US market represents more than 40% of the global market for medical devices. Yet for many manufacturers,
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Overview of the USA FDA Classification Process
Classification is arguably one of the most important steps in the US FDA medical device approval process. Understanding how the US FDA classifies
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In Depth: 21 CFR Part 820 - FDA Quality System Regulation
Are you ready to sell your medical device in the United States? If so, your company must comply with the US FDA Quality System Regulation (QSR),
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How to Prepare for an FDA Inspection
Are you ready for a random audit by the FDA? If you are lucky, you might only have a few weeks or even days to get ready for a visit from the FDA.
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