The document at the link provided is a short checklist for helping ensure or assess requirements quality. It is an educational aid to be used only by knowledgeable individuals and should not be used blindly or considered comprehensive. This was prepared by Brian Pate with input from Alan Kusinitz. Requirement Quality ChecklistRead More
IEC 80002-1 “Guidance on the application of ISO 14971 to medical device software” has been reconfirmed with a new stability date of 2016. This means that the document will not change before 2016. The next review to determine if the technical report should be revised will occur in 2015. IEC 80001-1 “Application of risk management...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 email@example.com for more info.