For those currently or intending to distribute electronic labeling for their medical devices, be aware that in 2010 FDA issued a guidance entitled “Addition of URL to Electronic Product Labeling”. This guidance contains a recommendation: “ …that manufacturers include their Uniform Resource Locator (URL) on their electronic product labels in addition to the requirements under...Read More
CSV Training Course
Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email firstname.lastname@example.org for more info.