Rac device exam prep 2024 - Study guides, Class notes & Summaries

RAC (Device) Exam Prep 2024 A manufacturer sells 1,500 medical devices in the two months following launch. A user, but not a patient, is seriously injured while using the medical device. The investigation reveals the cause to be an error in a software subroutine that has a one in 195,000 chance of happening. Management is concerned about how the incident may result in serious problems in the marketplace. What recommendation is MOST appropriate for the regulatory professional to make to mana...