Risk/hazard analysis for medical devices and their software require extensive analysis, documentation, and maintenance of complex information. Creation and maintenance of extensive tables, fault tree, and HAZOP diagrams can seem overwhelming. For complex and high risk systems the information can be voluminous and software tools can be very productive. Trace tools such as DOORS, CALIBER-RM,...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.