medical device design white papers

21 CFR Part 820 and cGMPs

All About FDA 21 CFR Part 820 and cGMPs

21 CFR Part 820 is a set of FDA regulations that govern medical device quality systems. Detailed within are current good manufacturing practice (cGMP) requirements ensuring medical devices distributed within the United States are effective, safe,

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Everything You Need to Know About Nitinol

Nitinol (pronounced night-in-all) is a metal alloy with unique properties and uses. This amazing metal alloy can “remember” or change shape depending on temperature. Before you decide whether to use nitinol in your medical device

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