FDA issued a Safety Communication on January 31, 2019, (see Safety Communication Link) warning of the risk of air being introduced in a blood vessel (air-in-line) and air embolism for infusion pumps, fluid warmers, rapid infusers, and accessory devices. This communication is directed toward users (both clinical and service personnel) and patients. However, what can system architects,...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.