BME Week 5 Exam Questions &
Answers (Grade A+)
MDR -
correct answer ✅Medical Device reporting
Post market surveillance study -
correct answer ✅manufacturer of class 2 or 3 to conduct a study if
failure of device could cause serious consequence.
Certification process -
correct answer ✅safe and effective
Certification of ECG process -
correct answer ✅worries about electric shock, distorted signal
could lead to wrong medical treatment
Battery operated thermometer risk -
correct answer ✅display wrong temperature could be detrimental
to patient because doctor wouldn't know the severity of patients
condition
Certification process main hazards -
correct answer ✅electrical hazards, mechanical hazards, radiation
hazards, fire, spillage, biocompatibility
Answers (Grade A+)
MDR -
correct answer ✅Medical Device reporting
Post market surveillance study -
correct answer ✅manufacturer of class 2 or 3 to conduct a study if
failure of device could cause serious consequence.
Certification process -
correct answer ✅safe and effective
Certification of ECG process -
correct answer ✅worries about electric shock, distorted signal
could lead to wrong medical treatment
Battery operated thermometer risk -
correct answer ✅display wrong temperature could be detrimental
to patient because doctor wouldn't know the severity of patients
condition
Certification process main hazards -
correct answer ✅electrical hazards, mechanical hazards, radiation
hazards, fire, spillage, biocompatibility
