FDA Medical Device eCopy webpage updated

The FDA maintains a webpage of resource at the link provided s for their eCopy program for medical device submissions. This addresses IDEs, premarket submissions and registration and listing. FDA also provides several tools for formatting and validating eCopy submissions.

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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