Biomedical Engineering Management Quiz

What is the primary focus of Safety Standards in medical devices?

• To ensure performance is satisfactory

• To define quality management systems

• To establish user training protocols

• To maintain electrical safety

Which of the following is an example of a Quality Standard?

• ISO 13485

• AAMI Standard

• IEC 60601

• MS 2058

What does MS 2058 primarily address?

• Quality management of medical devices

• Maintenance management of active medical devices

• Risk management in healthcare

• Electrical safety of medical equipment

According to ISO 14971, which of the following is NOT a part of the risk management process?

• Risk analysis

• Risk evaluation

• Risk documentation

• Risk control

What is the purpose of the Good Distribution Practice for Medical Devices (GDPMD)?

• To provide guidelines for user training

• To establish safety standards

• To ensure quality management systems

• To manage activities in the medical device supply chain

Which clause in MS 2058 addresses user maintenance?

• Clause 5

• Clause 7

• Clause 10

• Clause 12

What is the main objective of ISO 13485?

• To establish a quality management system for medical devices

• To define performance standards

• To ensure electrical safety

• To provide guidelines for maintenance

Which of the following is a responsibility of Biomedical Technical Personnel (BTP)?

• Managing warranties

• Developing quality assurance programs

• Performing scheduled maintenance

• Conducting risk assessments

What is the significance of Clause 18 in MS 2058?

• User training

• Incident investigation and reporting

• Procurement of active medical devices

• Disposal of active medical devices

Which standard provides guidance on the disposal of medical devices?

• ISO 13485

• MS 2650

• IEC 60601

• GDPMD