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CPMS Certified Professional for Medical Software VIP Exam
CPMS — The CPMS (Certified Professional for Medical Software) certification is offered by iSQI (International Software Quality Institute) and targets software professionals working on medical device software; the real exam covers IEC 62304, ISO 14971, ISO 13485, FDA 21 CFR Part 820/11, and EU MDR regulatory frameworks, with approximately 60 questions in 90 minutes at a 75% pass threshold.
30
Questions
90m
Time Limit
75.00%
To Pass
Question 1 of 30👑 VIP
A software development team is building firmware for an implantable cardiac monitor. During the hazard analysis, they identify a software failure mode that could cause the device to fail to deliver a life-saving alert, potentially resulting in patient death. According to IEC 62304, what Software Safety Class must be assigned to the software unit responsible for alert generation?
Questions 2–30 and full explanations are VIP-exclusive.