Day

November 14, 2010
The pdf at the link provided is a list of detectable flaws which a manufacturer could be expected to identify and remove. This was provided to the 62304 working group by the FDA for consideration during the work on the second edition of 62304.
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This website provides access to the latest lists of references of harmonised standards and other European standards. “Manufacturers, other economic operators, or conformity assessment bodies can use harmonised standards to demonstrate that products, services, or processes comply with relevant EU legislation.”
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CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

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