RAC (Device) Exam Prep 2024

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 management? A. Complete a product recall for the 1,500 medical devices already sold. B. Complete a corrective action following the manufacturer's procedures. C. Discuss the incident with the authorities, explaining the small margin of error. D. Discuss the incident with the authorities and send an advisory letter to each customer. - D. Discuss the incident with the authorities and send an advisory letter to each customer. An adverse event has been reported in connection with a medical device. When assessing the link between the device and the adverse event, which of the following is the LEAST relevant? A. Complaint trends from users B. Cost of medical device replacement C. Information concerning previous, similar events D. Opinions from healthcare professionals - B. Cost of medical device replacement During a routine inspection of the promotional materials of a medical device, the regulatory professional notices a factual error. This error could potentially lead to an incorrect usage of the device. A search of the company's safety database finds multiple reported events due to the error, none of which was serious. The IFU for the medical device contain the correct information. According to GHTF guidelines, does this error need to be reported?