Risk Management Training – MCQ Welcome to your Risk Management Training – MCQ Name Email 1. Which competence of the risk management team is missing the most according to TÜV SÜD’s experience: Technical knowledge Methodological knowledge Medical knowledge None 2. Please indicate all correct statements regarding probability classes: The probability needs a unit (e.g. per device and year). The probability needs a concrete number (e.g. 0,1%). The ranges of each probability class must be clear (e.g. 10 < x < 1000). Each probability class needs a spread of at least 10 (e.g. 10 < x < 100). 3. Please indicate all harms (following the definition of ISO 14971): Blood pump running too fast Cut in the finger Tissue damage False numbers on display 4. Please indicate all correct statements regarding the verification of risk control measures: The verification whether a warning is present in the user manual is a verification of effectiveness. The verification whether a break can stop a surgical robot arm within a safe range is a verification of effectiveness. Information for safety (e.g. warnings in the user manual) can be checked for effectiveness in a usability evaluation. Verification of correct implementation and effectiveness are the same. 5. The Regulations require Manufacturers to: establish, document, implement and maintain a risk management system establish and document a risk management system to consider implementing a formal risk management system None 6. Please indicate the correct statement(s): Risk management and clinical evaluation processes are managed separately as they involve different competency Risk management and clinical evaluation processes should be inter-dependent and should be regularly updated Risk management and clinical evaluation processes should be aligned 7. Notified Bodies are: Not required to address the interface between risk and clinical systems Required to address the interface between risk and clinical systems None 8. It is acceptable to only reduce risk as low as reasonably practicable: True False None 9. In which GSPR is the requirement to evaluate the impact of information from the production phase: GSPR 1 GSPR 2 GSPR 3 GSPR 4 None 10. The Regulations do not require ALL residual risks to be communicated to the user: True False None 11. Risk should be reduced: As far as possible until no risk remains As far as possible without adversely affecting benefit:risk ratio None 12. What is the definition of RISK: The likelihood of an accident combined with the likelihood of a hazard Combination of hazardous situation and the probability of related harm Combination of the probability of occurrence of harm and the severity of that harm None 13. The following three are examples of what? : Electric energy, Radiation, Bacteria Risks Harms Hazards Hazardous situations None 14. Are use errors included in Reasonably foreseeable use/misuse: Yes No None 15. “Process in which decisions are made and measures implemented by which risks are reduced” is a definition of what? : Risk Assessment Risk Control Risk Analysis Risk Management Review None 16. What is the definition of “Residual Risk”? : process in which decisions are made and measures implemented by which risks are reduced to, or maintained within, specified levels materials accompanying a medical device and containing information for the user or those accountable for the installation, use, maintenance, decommissioning and disposal of the medical device, particularly regarding safe use systematic use of available information to identify hazards and to estimate the risk risk remaining after risk control measures have been implemented None Time's up pascaleperspectives2025-02-20T13:13:09+01:00
