Q.1 Which U.S. law primarily protects the privacy of health information for users of rehabilitation engineering devices?
The Americans with Disabilities Act (ADA)
The Health Insurance Portability and Accountability Act (HIPAA)
The Rehabilitation Act of 1973
The Occupational Safety and Health Act (OSHA)
Explanation - HIPAA sets standards for protecting individually identifiable health information, which applies to data collected by rehabilitation devices.
Correct answer is: The Health Insurance Portability and Accountability Act (HIPAA)
Q.2 In the context of rehabilitation engineering, the principle of "informed consent" requires that:
The patient signs a contract for payment before device use
The patient is given detailed information about risks, benefits, and alternatives before agreeing to use a device
The engineer obtains verbal approval from a family member
The device is approved by the FDA
Explanation - Informed consent ensures that patients understand and voluntarily agree to the intervention after being informed of all relevant aspects.
Correct answer is: The patient is given detailed information about risks, benefits, and alternatives before agreeing to use a device
Q.3 Which international standard addresses the safety requirements for medical electrical equipment, including rehabilitation devices?
ISO 9001
IEC 60601-1
IEEE 802.11
ISO 14001
Explanation - IEC 60601-1 is the globally recognized standard for the safety and essential performance of medical electrical equipment.
Correct answer is: IEC 60601-1
Q.4 A rehabilitation device manufacturer wants to market a new prosthetic limb in the EU. Which regulatory pathway must they follow?
FDA 510(k) clearance
CE marking under the Medical Device Regulation (MDR)
Canadian Medical Device Regulations (CMDR) approval
None, only FDA approval is required
Explanation - In the European Union, medical devices must obtain CE marking under the MDR before they can be marketed.
Correct answer is: CE marking under the Medical Device Regulation (MDR)
Q.5 The principle of "beneficence" in biomedical ethics requires that a rehabilitation engineer should:
Maximize profits from device sales
Ensure the device does no harm and promotes the patient's well-being
Provide the device to the first patient who requests it
Delegate all decisions to the manufacturer
Explanation - Beneficence obligates professionals to act in the best interest of the patient, promoting health and preventing harm.
Correct answer is: Ensure the device does no harm and promotes the patient's well-being
Q.6 Which act mandates that public facilities, including rehabilitation centers, must be accessible to individuals with disabilities in the United States?
The Rehabilitation Act of 1973
The Americans with Disabilities Act (ADA)
The Individuals with Disabilities Education Act (IDEA)
The Fair Housing Act
Explanation - The ADA requires that public accommodations be accessible, influencing the design of rehabilitation facilities and devices.
Correct answer is: The Americans with Disabilities Act (ADA)
Q.7 When performing a risk-benefit analysis for a new exoskeleton, which of the following is the most appropriate first step?
Estimating the manufacturing cost
Identifying potential hazards associated with device use
Marketing the device to clinicians
Applying for a patent
Explanation - Risk-benefit analysis begins with hazard identification to evaluate and mitigate possible adverse events.
Correct answer is: Identifying potential hazards associated with device use
Q.8 A conflict of interest arises when a rehabilitation engineer:
Uses open‑source software in a device
Has a financial stake in a company whose device they are recommending
Participates in a clinical trial
Attends a professional conference
Explanation - Personal financial interest that could bias professional judgment constitutes a conflict of interest.
Correct answer is: Has a financial stake in a company whose device they are recommending
Q.9 Which of the following best describes the purpose of post‑market surveillance for rehabilitation devices?
To assess device performance after it has been released to users
To design the device's user interface
To calculate the device's manufacturing cost
To secure funding for research
Explanation - Post‑market surveillance monitors safety and efficacy of a device in real‑world use, identifying any emerging issues.
Correct answer is: To assess device performance after it has been released to users
Q.10 Under the principle of "justice" in biomedical ethics, a rehabilitation engineer should:
Prioritize patients who can pay more for the device
Ensure fair distribution of devices regardless of socioeconomic status
Develop devices only for elite athletes
Ignore accessibility considerations
Explanation - Justice requires equitable access to healthcare resources, including assistive technologies.
Correct answer is: Ensure fair distribution of devices regardless of socioeconomic status
Q.11 Which regulatory document outlines the requirements for labeling of medical devices in the United States?
21 CFR Part 820
21 CFR Part 801
21 CFR Part 11
21 CFR Part 50
Explanation - 21 CFR Part 801 specifies labeling requirements for medical devices, covering information that must appear on labels and packaging.
Correct answer is: 21 CFR Part 801
Q.12 A rehabilitation engineering research study involves collecting biometric data from participants. Which ethical principle primarily addresses how this data should be handled?
Non‑maleficence
Autonomy
Confidentiality
Beneficence
Explanation - Confidentiality ensures that personal data is protected and only shared with authorized parties.
Correct answer is: Confidentiality
Q.13 Which of the following is a key requirement of ISO 13485 for manufacturers of rehabilitation devices?
Implementation of a quality management system specific to medical devices
Providing free devices to low‑income patients
Ensuring devices are made only from biodegradable materials
Offering lifetime warranties on all products
Explanation - ISO 13485 focuses on quality management systems for the design and manufacture of medical devices.
Correct answer is: Implementation of a quality management system specific to medical devices
Q.14 The "right to refuse treatment" is most closely associated with which ethical principle?
Beneficence
Non‑maleficence
Autonomy
Justice
Explanation - Autonomy respects the individual's right to make decisions about their own body and treatment.
Correct answer is: Autonomy
Q.15 A rehabilitation device manufacturer discovers a defect after the product has been sold. The appropriate ethical action is to:
Ignore the defect if no injuries have been reported
Recall the device and notify users and regulators promptly
Wait for a competitor to issue a recall first
Only fix the defect in future production batches
Explanation - Prompt recall protects patients and fulfills legal and ethical obligations for safety.
Correct answer is: Recall the device and notify users and regulators promptly
Q.16 Which of the following best defines "accessibility" in the design of rehabilitation engineering products?
Making devices aesthetically pleasing
Ensuring devices can be used by the widest possible range of users, including those with disabilities
Reducing manufacturing costs
Limiting device use to trained professionals only
Explanation - Accessibility means designing products so they can be effectively used by people with diverse abilities.
Correct answer is: Ensuring devices can be used by the widest possible range of users, including those with disabilities
Q.17 Which U.S. regulation governs the clinical investigation of medical devices, including those used in rehabilitation?
21 CFR Part 812
21 CFR Part 820
21 CFR Part 11
21 CFR Part 50
Explanation - Part 812 outlines requirements for investigational device exemptions (IDEs) and clinical trials.
Correct answer is: 21 CFR Part 812
Q.18 When a rehabilitation engineer is asked to design a device for a specific patient, the ethical approach to personalization is to:
Create a one‑size‑fits‑all solution
Consider the patient's unique needs while ensuring safety and efficacy
Ignore the patient's preferences to speed up development
Charge a premium for customization regardless of need
Explanation - Personalization must balance individual needs with rigorous safety standards.
Correct answer is: Consider the patient's unique needs while ensuring safety and efficacy
Q.19 Which of the following is NOT a typical component of an Institutional Review Board (IRB) review for a rehabilitation engineering study?
Assessment of risk versus benefit
Evaluation of scientific merit
Verification of the engineer's salary
Review of informed consent procedures
Explanation - IRBs focus on participant protection and study integrity, not staff compensation.
Correct answer is: Verification of the engineer's salary
Q.20 The term "dual use" in the context of rehabilitation technology refers to:
Devices that can be used for both therapy and sport
Technology that can be applied for both civilian and military purposes
Products that have both hardware and software components
Devices that operate on both AC and DC power
Explanation - Dual‑use items have potential applications in both civilian rehabilitation and defense contexts, raising distinct ethical concerns.
Correct answer is: Technology that can be applied for both civilian and military purposes
Q.21 Which of the following best describes the ethical concept of "non‑maleficence"?
Do no harm to patients
Provide the best possible benefit
Allow patients to make their own choices
Distribute resources fairly
Explanation - Non‑maleficence obligates professionals to avoid causing harm.
Correct answer is: Do no harm to patients
Q.22 A rehabilitation engineering firm wants to share anonymized usage data with a research university. Which ethical principle must they most carefully uphold?
Autonomy
Beneficence
Justice
Confidentiality
Explanation - Even anonymized data must be handled to protect patient privacy and maintain confidentiality.
Correct answer is: Confidentiality
Q.23 Under the EU Medical Device Regulation, which class would a simple, non‑invasive orthotic brace most likely fall into?
Class I
Class IIa
Class IIb
Class III
Explanation - Class I includes low‑risk devices such as non‑invasive orthoses.
Correct answer is: Class I
Q.24 Which of the following is an example of a violation of the principle of beneficence in rehabilitation engineering?
Providing a prosthetic limb that improves mobility
Skipping safety testing to accelerate market launch, endangering users
Offering a device at a reduced price for low‑income patients
Conducting a thorough risk assessment before release
Explanation - Neglecting safety undermines the duty to promote the patient's well‑being.
Correct answer is: Skipping safety testing to accelerate market launch, endangering users
Q.25 Which regulatory body is responsible for approving medical devices, including rehabilitation equipment, in the United States?
Food and Drug Administration (FDA)
Centers for Disease Control and Prevention (CDC)
National Institutes of Health (NIH)
Environmental Protection Agency (EPA)
Explanation - The FDA regulates the safety and efficacy of medical devices in the U.S.
Correct answer is: Food and Drug Administration (FDA)
Q.26 When a rehabilitation engineer designs a device that collects data from a patient’s brain signals, which additional ethical consideration is most prominent?
Battery life
Data security and neural privacy
Color of the device
Manufacturing cost
Explanation - Brain‑derived data is highly sensitive, requiring robust privacy safeguards.
Correct answer is: Data security and neural privacy
Q.27 The term "equitable access" in the context of rehabilitation technology most closely aligns with which ethical principle?
Beneficence
Justice
Autonomy
Non‑maleficence
Explanation - Justice emphasizes fair distribution of resources and services.
Correct answer is: Justice
Q.28 Which of the following statements about a 510(k) submission is true?
It is required for all medical devices before any market entry
It demonstrates that a new device is substantially equivalent to a legally marketed predicate device
It replaces the need for post‑market surveillance
It is only used for drug‑device combinations
Explanation - A 510(k) pathway shows substantial equivalence to an existing device, allowing market clearance.
Correct answer is: It demonstrates that a new device is substantially equivalent to a legally marketed predicate device
Q.29 A rehabilitation engineer discovers that a competitor's device uses a patented algorithm without permission. The appropriate ethical response is to:
Ignore it because patents are not important
Publicly shame the competitor on social media
Report the infringement to the patent holder or appropriate authority
Copy the algorithm for their own device
Explanation - Respecting intellectual property protects innovation and follows ethical standards.
Correct answer is: Report the infringement to the patent holder or appropriate authority
Q.30 Which of the following best illustrates the concept of "patient‑centered design" in rehabilitation engineering?
Designing a wheelchair based solely on engineering specifications
Involving end‑users throughout the design process to tailor functionality to their daily lives
Choosing the cheapest components to reduce cost
Following a standard template for all devices
Explanation - Patient‑centered design actively incorporates user feedback to meet real‑world needs.
Correct answer is: Involving end‑users throughout the design process to tailor functionality to their daily lives
Q.31 A rehabilitation device is marketed with claims that are not supported by clinical evidence. This practice violates:
The principle of autonomy
The principle of justice
Regulatory advertising standards and ethical truthfulness
The principle of beneficence
Explanation - Misleading claims breach both regulatory rules and the ethical duty to be truthful.
Correct answer is: Regulatory advertising standards and ethical truthfulness
Q.32 In a clinical trial of a new rehabilitation exoskeleton, which document outlines participants’ rights and the study’s risks?
Device user manual
Informed consent form
FDA 510(k) summary
Patent application
Explanation - The informed consent form informs participants of risks, benefits, and their rights.
Correct answer is: Informed consent form
Q.33 Which of the following is a primary goal of the International Electrotechnical Commission (IEC) standards for medical devices?
To standardize color schemes
To ensure safety and performance across international markets
To regulate pricing
To define marketing strategies
Explanation - IEC standards aim to harmonize safety and performance requirements globally.
Correct answer is: To ensure safety and performance across international markets
Q.34 A rehabilitation engineer is asked to share source code for a proprietary algorithm with a competitor under pressure. The ethical course of action is to:
Share it freely to promote collaboration
Refuse and protect intellectual property while seeking legal guidance
Delete the code
Sell the code to the highest bidder
Explanation - Protecting proprietary information upholds intellectual‑property rights and professional integrity.
Correct answer is: Refuse and protect intellectual property while seeking legal guidance
Q.35 Which act specifically addresses the rights of individuals with disabilities to receive appropriate educational services, indirectly influencing rehabilitation engineering in schools?
The Individuals with Disabilities Education Act (IDEA)
The Americans with Disabilities Act (ADA)
The Rehabilitation Act of 1973
The Fair Labor Standards Act
Explanation - IDEA ensures access to education and related services, guiding assistive technology use in schools.
Correct answer is: The Individuals with Disabilities Education Act (IDEA)
Q.36 When conducting usability testing for a new wheelchair control interface, the engineer should prioritize:
Aesthetic appeal over function
Ease of use, safety, and user satisfaction
Speed of development over user feedback
Manufacturing cost reduction
Explanation - Usability testing focuses on how effectively and safely users can operate the device.
Correct answer is: Ease of use, safety, and user satisfaction
Q.37 Which of the following best describes an "adverse event" in the context of medical device regulation?
A successful clinical trial outcome
Any undesirable experience associated with the use of a medical device
A marketing campaign that fails
A device that is discontinued for economic reasons
Explanation - Adverse events include any negative health incident related to device use, requiring reporting.
Correct answer is: Any undesirable experience associated with the use of a medical device
Q.38 The principle of "respect for persons" combines which two ethical concepts?
Autonomy and non‑maleficence
Beneficence and justice
Autonomy and dignity
Justice and confidentiality
Explanation - Respect for persons emphasizes individuals' right to self‑determination and inherent dignity.
Correct answer is: Autonomy and dignity
Q.39 In the EU, the term "Notified Body" refers to:
A government agency that bans medical devices
An organization designated to assess conformity of devices with EU regulations
A patient advocacy group
A funding agency for research
Explanation - Notified Bodies perform conformity assessments required for CE marking.
Correct answer is: An organization designated to assess conformity of devices with EU regulations
Q.40 Which of the following is a key ethical concern when using AI algorithms in adaptive prosthetic control?
Battery size
Algorithmic bias that may affect performance for different users
Cable length
Color of the prosthetic
Explanation - Bias in AI can lead to unequal outcomes, raising ethical concerns about fairness.
Correct answer is: Algorithmic bias that may affect performance for different users
Q.41 A rehabilitation engineer is planning to use patient data for a new device algorithm. Which step ensures compliance with ethical data use?
Publishing the data without consent
Obtaining explicit informed consent for data use
Sharing the data on social media
Selling the data to third parties
Explanation - Consent is required to ethically and legally use personal health data.
Correct answer is: Obtaining explicit informed consent for data use
Q.42 Which regulation would most likely govern the export of a high‑risk rehabilitation robot from the United States?
Export Administration Regulations (EAR)
Clean Air Act
Food Safety Modernization Act
National Labor Relations Act
Explanation - EAR controls the export of dual‑use and high‑technology items, including advanced medical robots.
Correct answer is: Export Administration Regulations (EAR)
Q.43 When a rehabilitation device is labeled as "for investigational use only," this means:
It can be sold to the general public
It is approved for widespread clinical use
It may be used only in a research setting under an IDE
It is free of charge for patients
Explanation - Investigational devices are limited to controlled research studies pending approval.
Correct answer is: It may be used only in a research setting under an IDE
Q.44 Which ethical principle is most directly related to the requirement that a rehabilitation engineer must disclose any financial relationships with device manufacturers to patients?
Beneficence
Justice
Transparency (part of respect for persons)
Non‑maleficence
Explanation - Disclosing conflicts of interest upholds honesty and respects patient autonomy.
Correct answer is: Transparency (part of respect for persons)
Q.45 In the context of assistive technology, the term "universal design" means:
Designing for a single user demographic
Creating products that are usable by the greatest number of people without adaptation
Manufacturing only one model of a device
Designing exclusively for children
Explanation - Universal design seeks to accommodate diverse users from the outset.
Correct answer is: Creating products that are usable by the greatest number of people without adaptation
Q.46 A post‑market report reveals that a newly released rehabilitation orthosis has a higher than expected failure rate. The manufacturer should:
Ignore the data because the product is already sold
Issue a field safety notice and conduct a root‑cause analysis
Increase the price to cover potential liabilities
Discontinue all research activities
Explanation - Prompt action protects patients and complies with regulatory requirements.
Correct answer is: Issue a field safety notice and conduct a root‑cause analysis
Q.47 Which of the following is considered a protected health information (PHI) under HIPAA?
The brand of a wheelchair used by a patient
A patient’s name combined with their diagnosis
The color of a prosthetic socket
The model number of a medical device
Explanation - PHI includes any individually identifiable health information.
Correct answer is: A patient’s name combined with their diagnosis
Q.48 When a rehabilitation engineer uses a crowdsourced dataset of gait patterns without verifying consent, the primary ethical breach is:
Violation of non‑maleficence
Violation of confidentiality and informed consent
Violation of beneficence
Violation of justice
Explanation - Using data without proper consent breaches privacy and informed‑consent standards.
Correct answer is: Violation of confidentiality and informed consent
Q.49 The principle of "least restrictive alternative" in rehabilitation engineering implies:
Choosing the cheapest material available
Providing the most restrictive device to ensure safety
Selecting an intervention that imposes the minimum necessary limitations on patient autonomy
Avoiding any device usage altogether
Explanation - The least restrictive alternative respects autonomy while achieving therapeutic goals.
Correct answer is: Selecting an intervention that imposes the minimum necessary limitations on patient autonomy
Q.50 Which document is required for a medical device to demonstrate compliance with the FDA’s Quality System Regulation (QSR) before market entry?
Design History File (DHF)
Device Master Record (DMR)
Premarket Approval (PMA) application
Both DHF and DMR as part of the QSR
Explanation - The QSR requires maintenance of design history and device master records for compliance.
Correct answer is: Both DHF and DMR as part of the QSR
Q.51 A rehabilitation engineer is developing a device for children with cerebral palsy. Which ethical consideration should be given special attention?
Ensuring the device is marketed to adults first
Obtaining assent from the child in addition to parental consent
Using only adult-sized components
Skipping safety testing because children recover quickly
Explanation - Children’s assent respects their developing autonomy while parents give consent.
Correct answer is: Obtaining assent from the child in addition to parental consent
Q.52 Which of the following best describes the purpose of a "Medical Device Reporting (MDR)" system in the United States?
To report financial earnings of device companies
To notify the FDA of adverse events and product problems
To track inventory levels of medical devices
To advertise new devices to clinicians
Explanation - MDR is a mandatory reporting system for device-related adverse events.
Correct answer is: To notify the FDA of adverse events and product problems
Q.53 Which of the following is a key requirement of the FDA’s Human Factors Engineering (HFE) guidance for medical devices?
Designing devices with minimal user interaction
Conducting usability testing to assess how users interact with the device
Eliminating all software components
Ensuring devices are made of only metal
Explanation - HFE guidance emphasizes understanding user interaction to reduce use‑related errors.
Correct answer is: Conducting usability testing to assess how users interact with the device
Q.54 In a low‑resource setting, a rehabilitation engineer must balance cost and safety. Which ethical principle guides ensuring the device does not expose users to undue risk, even if it raises cost?
Beneficence
Justice
Non‑maleficence
Autonomy
Explanation - Non‑maleficence prioritizes avoiding harm, even when cost constraints exist.
Correct answer is: Non‑maleficence
Q.55 Which of the following statements about the "right to repair" movement is most relevant to rehabilitation engineers?
It encourages manufacturers to provide service manuals and spare parts to extend device lifespan
It mandates that all devices be disposable after one year
It requires that all devices be made of recycled materials
It bans the use of software updates
Explanation - The right‑to‑repair aims to improve accessibility and sustainability of assistive devices.
Correct answer is: It encourages manufacturers to provide service manuals and spare parts to extend device lifespan
Q.56 When a rehabilitation engineer conducts a literature review, they must avoid which unethical practice?
Citing all relevant sources
Plagiarizing text from other authors without attribution
Including both positive and negative findings
Using peer‑reviewed journals
Explanation - Plagiarism breaches academic integrity and intellectual property rights.
Correct answer is: Plagiarizing text from other authors without attribution
Q.57 Which of the following best describes a "human subject" under U.S. research regulations?
Any person who interacts with a medical device for marketing purposes
Any living individual about whom a researcher obtains data through intervention or interaction
Only patients with disabilities
Only physicians involved in a study
Explanation - Human subjects include any individuals from whom data is collected via intervention, observation, or interaction.
Correct answer is: Any living individual about whom a researcher obtains data through intervention or interaction
Q.58 A rehabilitation engineer designs a smart prosthetic that streams user data to cloud servers. Which regulation is most likely to apply to the data transmission?
The Clean Water Act
The Health Insurance Portability and Accountability Act (HIPAA)
The Federal Aviation Regulations
The Fair Trade Act
Explanation - HIPAA governs protected health information, including data transmitted from medical devices.
Correct answer is: The Health Insurance Portability and Accountability Act (HIPAA)
Q.59 Which ethical principle supports involving patients in decision‑making about the selection of a rehabilitation device?
Beneficence
Non‑maleficence
Autonomy
Justice
Explanation - Autonomy emphasizes respecting the patient's right to make informed choices.
Correct answer is: Autonomy
Q.60 During a design review, an engineer discovers that a component used in a prosthetic limb is sourced from a supplier that employs child labor. The appropriate ethical response is to:
Continue using the component to avoid delays
Report the issue and source an ethical alternative
Ignore the information because it does not affect device function
Hide the source from management
Explanation - Using ethically sourced components aligns with broader social responsibility and justice.
Correct answer is: Report the issue and source an ethical alternative
Q.61 Which of the following is a core element of a risk management file for a medical device under ISO 14971?
Market analysis report
Risk analysis, evaluation, control, and post‑production information
Employee salary schedule
Advertising plan
Explanation - ISO 14971 requires a comprehensive risk management process throughout the device lifecycle.
Correct answer is: Risk analysis, evaluation, control, and post‑production information
Q.62 A rehabilitation engineer wants to reuse a patented sensor design in a new device. Which legal mechanism allows this under certain conditions?
Fair use doctrine
Patent licensing agreement
Trade secret protection
Trademark registration
Explanation - A licensing agreement permits lawful use of patented technology.
Correct answer is: Patent licensing agreement
Q.63 Which of the following best reflects the concept of "patient safety culture" in a rehabilitation engineering organization?
Prioritizing speed of product release over safety testing
Encouraging staff to report safety concerns without fear of reprisal
Keeping safety protocols confidential from employees
Limiting training to senior engineers only
Explanation - A safety culture promotes open communication about risks and continuous improvement.
Correct answer is: Encouraging staff to report safety concerns without fear of reprisal
Q.64 In the context of rehabilitation engineering, the term "assistive technology" is defined by which U.S. act?
The Rehabilitation Act of 1973
The Americans with Disabilities Act (ADA)
The Assistive Technology Act of 1998
The Federal Trade Commission Act
Explanation - The Assistive Technology Act promotes access to assistive technology for individuals with disabilities.
Correct answer is: The Assistive Technology Act of 1998
Q.65 A rehabilitation engineer is reviewing a device’s software for compliance. Which standard specifically addresses the lifecycle processes for medical device software?
ISO 14971
IEC 62304
ISO 9001
IEEE 802.3
Explanation - IEC 62304 provides requirements for software development and maintenance of medical devices.
Correct answer is: IEC 62304
Q.66 When a device manufacturer claims that their rehabilitation robot is "clinically proven" without providing supporting data, this practice violates:
The principle of beneficence
The principle of autonomy
Regulatory truth-in-advertising rules and ethical honesty
The principle of non‑maleficence
Explanation - Unsubstantiated claims are deceptive and breach both regulations and ethical standards.
Correct answer is: Regulatory truth-in-advertising rules and ethical honesty
Q.67 Which of the following is a requirement for a device to be classified as a "medical device" under the FDA definition?
It must be used for diagnosing, curing, mitigating, treating, or preventing disease
It must be purely cosmetic
It must be a food supplement
It must be a general wellness product with no medical claims
Explanation - The FDA defines medical devices based on their intended medical purpose.
Correct answer is: It must be used for diagnosing, curing, mitigating, treating, or preventing disease
Q.68 In a rehabilitation engineering project, the engineer is asked to hide a known defect from users to avoid negative publicity. The appropriate ethical response is to:
Hide the defect and continue sales
Disclose the defect to users and take corrective action
Blame the defect on a supplier
Ignore the issue because it does not affect device performance
Explanation - Transparency and patient safety outweigh concerns about reputation.
Correct answer is: Disclose the defect to users and take corrective action
Q.69 Which of the following best describes the concept of "inclusion" in the development of rehabilitation technologies?
Designing only for the most common disability
Involving diverse stakeholders, including people with different disabilities, in the design process
Limiting testing to a single demographic
Focusing solely on cost reduction
Explanation - Inclusion ensures that varied perspectives shape the technology to meet broad needs.
Correct answer is: Involving diverse stakeholders, including people with different disabilities, in the design process
Q.70 A rehabilitation device is found to emit electromagnetic interference (EMI) that disrupts nearby medical equipment. This issue primarily concerns which aspect of regulatory compliance?
Labeling requirements
Electromagnetic compatibility (EMC) standards
Environmental impact assessments
Software validation
Explanation - EMC standards ensure devices do not cause harmful interference with other equipment.
Correct answer is: Electromagnetic compatibility (EMC) standards
Q.71 Which principle of biomedical ethics emphasizes that the benefits of a rehabilitation device should outweigh its risks?
Justice
Autonomy
Beneficence
Non‑maleficence
Explanation - Beneficence requires that actions promote well‑being and that benefits exceed harms.
Correct answer is: Beneficence
Q.72 A researcher wants to use a dataset of electromyography (EMG) signals collected from patients without obtaining consent. Which ethical principle is being violated?
Beneficence
Justice
Autonomy
Non‑maleficence
Explanation - Using data without consent disregards the participants' right to control their personal information.
Correct answer is: Autonomy
Q.73 Which of the following best describes the purpose of a "Device Master Record" (DMR) in the FDA's Quality System Regulation?
A collection of marketing materials
A compilation of all the specifications, drawings, and procedures needed to manufacture the device
A log of sales transactions
A list of employee salaries
Explanation - The DMR contains everything required to produce the device consistently and safely.
Correct answer is: A compilation of all the specifications, drawings, and procedures needed to manufacture the device
Q.74 When a rehabilitation engineer evaluates a new device, which ethical analysis helps determine whether the potential benefits justify the risks?
Cost‑benefit analysis
Risk‑benefit analysis
SWOT analysis
PESTLE analysis
Explanation - Risk‑benefit analysis directly compares potential harms against expected benefits.
Correct answer is: Risk‑benefit analysis
Q.75 Under the principle of "justice," how should a rehabilitation engineer address disparities in device availability between urban and rural patients?
Prioritize urban patients because they are easier to reach
Develop strategies to improve access for underserved rural populations
Ignore the disparity as it is not the engineer’s responsibility
Charge higher prices to rural patients to offset costs
Explanation - Justice calls for equitable distribution of healthcare resources.
Correct answer is: Develop strategies to improve access for underserved rural populations
Q.76 Which of the following is NOT a requirement of the FDA’s Good Manufacturing Practice (GMP) regulations for medical devices?
Establishing a quality system
Conducting regular device performance audits
Providing free devices to all patients
Documenting design changes
Explanation - GMP focuses on quality and safety, not on pricing or distribution policies.
Correct answer is: Providing free devices to all patients
Q.77 A rehabilitation engineer discovers that a device’s user interface is not intuitive for older adults. The most ethical course of action is to:
Leave the design unchanged to save costs
Redesign the interface to improve usability for the target demographic
Remove the device from the market entirely
Only provide a detailed user manual
Explanation - Improving usability aligns with beneficence and patient‑centered design.
Correct answer is: Redesign the interface to improve usability for the target demographic
Q.78 Which of the following best describes "dual‑use" research in the context of rehabilitation engineering?
Research that benefits both civilian patients and military personnel
Research that has both therapeutic and commercial applications
Research that can be used for both beneficial medical purposes and potential harmful applications
Research that is funded by two different agencies
Explanation - Dual‑use research poses ethical dilemmas because it may be repurposed for harmful uses.
Correct answer is: Research that can be used for both beneficial medical purposes and potential harmful applications
Q.79 Which regulatory document outlines the essential requirements for medical devices sold in Canada?
Health Canada Medical Device Regulations (MDR)
European Medical Device Regulation (MDR)
FDA 510(k) Guidance
Australian Therapeutic Goods Administration (TGA) Guidelines
Explanation - Canada’s MDR specifies safety and performance requirements for medical devices.
Correct answer is: Health Canada Medical Device Regulations (MDR)
Q.80 A rehabilitation engineering team is considering using a patient’s genetic data to personalize a prosthetic control algorithm. The most important ethical step before proceeding is:
Obtaining broad consent for any future use of data
Ensuring the data is stored without encryption
Informing the patient only after the algorithm is completed
Selling the data to a third‑party research firm
Explanation - Genetic data is highly sensitive; explicit consent is required for its use and sharing.
Correct answer is: Obtaining broad consent for any future use of data
Q.81 Which principle of bioethics is primarily concerned with ensuring that vulnerable populations are not exploited in rehabilitation engineering research?
Beneficence
Justice
Autonomy
Non‑maleficence
Explanation - Justice addresses fairness and protection of vulnerable groups from exploitation.
Correct answer is: Justice
Q.82 If a rehabilitation device fails to meet the electromagnetic compatibility (EMC) standards during testing, what is the most ethical action?
Ignore the result and proceed to market
Redesign the device to meet EMC standards before release
Reduce the price to compensate for the failure
Market the device only in regions without EMC regulations
Explanation - Ensuring compliance with safety standards is essential to protect users and meet regulatory obligations.
Correct answer is: Redesign the device to meet EMC standards before release
Q.83 Which of the following is an example of a "reasonable accommodation" for a user with limited hand dexterity when designing a control interface for a wheelchair?
Requiring complex multi‑button sequences
Providing a large, single‑press button with tactile feedback
Designing a control that requires precise finger movements
Eliminating all physical controls
Explanation - Reasonable accommodations adapt the device to the user's abilities, enhancing accessibility.
Correct answer is: Providing a large, single‑press button with tactile feedback
Q.84 A rehabilitation device is being used in a clinical trial without a proper Institutional Review Board (IRB) approval. This situation violates:
The principle of beneficence
Regulatory requirements for human subject protection
The principle of autonomy only
The principle of non‑maleficence only
Explanation - IRB approval is mandatory to protect participants in research involving human subjects.
Correct answer is: Regulatory requirements for human subject protection
Q.85 Which of the following best describes the concept of "inclusionary design" in rehabilitation engineering?
Designing devices exclusively for elite athletes
Creating devices that only meet minimum legal standards
Designing products that consider the diverse needs of all potential users from the outset
Limiting product features to reduce cost
Explanation - Inclusionary design seeks to serve a broad audience by addressing varied abilities and contexts.
Correct answer is: Designing products that consider the diverse needs of all potential users from the outset
Q.86 A rehabilitation engineer discovers that a competitor's device is marketed with exaggerated performance claims. The appropriate professional response is to:
Publicly criticize the competitor on social media
Report the misleading claims to the appropriate regulatory authority
Ignore it because competition is part of business
Copy the claims for their own product
Explanation - Reporting ensures truthfulness in the marketplace and protects patients from misinformation.
Correct answer is: Report the misleading claims to the appropriate regulatory authority
Q.87 Which ethical principle requires that a rehabilitation engineer disclose the limitations and uncertainties of a new device to the patient?
Beneficence
Non‑maleficence
Autonomy
Justice
Explanation - Full disclosure enables patients to make informed decisions, respecting their autonomy.
Correct answer is: Autonomy
Q.88 Under the EU’s General Data Protection Regulation (GDPR), which right allows patients to request deletion of their personal data collected by a rehabilitation device?
Right to be forgotten
Right to data portability
Right to rectification
Right to restriction of processing
Explanation - The right to be forgotten permits individuals to have personal data erased under certain conditions.
Correct answer is: Right to be forgotten
Q.89 A rehabilitation engineer is assessing whether to incorporate a new sensor that is not yet FDA‑cleared. The most ethical course of action is to:
Use it in patients immediately to gain a market advantage
Wait until the sensor receives proper regulatory clearance before clinical use
Ignore regulatory status and rely on internal testing only
Sell the sensor to patients directly
Explanation - Regulatory clearance ensures safety and efficacy before patient exposure.
Correct answer is: Wait until the sensor receives proper regulatory clearance before clinical use
Q.90 Which of the following best exemplifies the concept of "shared decision‑making" in rehabilitation engineering?
The clinician decides the device without patient input
The patient selects a device based solely on price
The engineer, clinician, and patient collaboratively discuss options, benefits, and risks before selecting a device
The manufacturer dictates which device must be used
Explanation - Shared decision‑making integrates professional expertise with patient values and preferences.
Correct answer is: The engineer, clinician, and patient collaboratively discuss options, benefits, and risks before selecting a device
Q.91 Which of the following is a key ethical concern when deploying a remote monitoring system for a home‑based rehabilitation robot?
Battery life of the robot
Ensuring data encryption and patient privacy during transmission
The robot’s aesthetic design
The speed of the robot’s movements
Explanation - Remote monitoring involves transmitting health data, making privacy and security paramount.
Correct answer is: Ensuring data encryption and patient privacy during transmission
Q.92 Which regulatory pathway is typically required for a Class III (high‑risk) implantable rehabilitation device in the United States?
510(k) clearance
De Novo classification
Premarket Approval (PMA)
Humanitarian Device Exemption (HDE)
Explanation - Class III devices usually require the more rigorous PMA process to demonstrate safety and effectiveness.
Correct answer is: Premarket Approval (PMA)
Q.93 When a rehabilitation engineer is developing a device for a culturally diverse population, which ethical consideration is most important?
Using only one language for the user interface
Ensuring the device respects cultural norms and values of all target users
Choosing the cheapest materials regardless of cultural impact
Standardizing the device to a single cultural model
Explanation - Cultural sensitivity promotes respect, acceptance, and effective use across diverse groups.
Correct answer is: Ensuring the device respects cultural norms and values of all target users
Q.94 Which of the following is a core component of the FDA’s post‑market surveillance requirements for medical devices?
Annual financial audits
Periodic safety reporting (e.g., MDRs, recalls)
Marketing campaign approvals
Employee performance reviews
Explanation - Post‑market surveillance involves ongoing monitoring and reporting of device safety issues.
Correct answer is: Periodic safety reporting (e.g., MDRs, recalls)
Q.95 A rehabilitation engineer discovers that a device's software update may compromise patient data security. The ethical action is to:
Release the update quickly to fix other bugs
Delay the update until security issues are resolved and inform users of the risk
Ignore the issue because software updates are routine
Sell the update to another company
Explanation - Prioritizing data security protects patient privacy and aligns with ethical obligations.
Correct answer is: Delay the update until security issues are resolved and inform users of the risk
Q.96 Which of the following best captures the meaning of "patient autonomy" in the context of selecting a rehabilitation device?
Patients must accept whatever device the clinician recommends
Patients have the right to make an informed choice about their own care
Patients are required to follow the manufacturer’s guidelines strictly
Patients cannot refuse a device once it is prescribed
Explanation - Autonomy respects the individual's right to self‑determination based on adequate information.
Correct answer is: Patients have the right to make an informed choice about their own care
Q.97 The principle of "non‑maleficence" requires a rehabilitation engineer to:
Maximize profit from device sales
Ensure that the device does not cause harm to the user
Provide the device to everyone regardless of need
Promote the device aggressively in marketing
Explanation - Non‑maleficence is the duty to avoid causing harm.
Correct answer is: Ensure that the device does not cause harm to the user
Q.98 Which international classification system helps standardize the functional abilities that rehabilitation devices aim to support?
ICD‑10
ICF (International Classification of Functioning, Disability and Health)
DSM‑5
CPT coding
Explanation - The ICF provides a framework for describing health and disability, guiding device development.
Correct answer is: ICF (International Classification of Functioning, Disability and Health)
Q.99 When a rehabilitation device is used in a low‑resource setting, the ethical principle that emphasizes balancing cost with safety is:
Beneficence
Justice
Non‑maleficence
Autonomy
Explanation - Non‑maleficence requires that cost‑saving measures do not compromise safety.
Correct answer is: Non‑maleficence
Q.100 A rehabilitation engineer is asked to develop a device that will be used in a conflict zone. Which ethical issue is most pertinent?
Ensuring the device has a bright color
Assessing the potential dual‑use implications and possible harm
Designing the device to be as complex as possible
Marketing the device to civilians only
Explanation - Dual‑use in conflict zones raises concerns about the device being used for harm, requiring careful ethical assessment.
Correct answer is: Assessing the potential dual‑use implications and possible harm
Q.101 Which of the following best illustrates a violation of the principle of "justice" in rehabilitation engineering?
Providing a device only to patients who can afford it while denying it to low‑income patients
Offering training to all clinicians
Designing a device with user‑friendly controls
Conducting thorough safety testing
Explanation - Justice demands fair distribution of resources regardless of socioeconomic status.
Correct answer is: Providing a device only to patients who can afford it while denying it to low‑income patients
Q.102 Which regulation specifically addresses the protection of human subjects in research conducted or supported by U.S. federal agencies?
The Common Rule (45 CFR 46)
The Clean Air Act
The Federal Food, Drug, and Cosmetic Act
The Occupational Safety and Health Act
Explanation - The Common Rule sets standards for informed consent, IRB review, and protection of participants.
Correct answer is: The Common Rule (45 CFR 46)
Q.103 A rehabilitation engineer is developing a device that records video of a patient’s movements for analysis. The most important ethical consideration is:
Resolution of the video camera
Ensuring patient consent for video recording and secure storage
The color of the device housing
The speed of data processing
Explanation - Video data is highly personal; consent and security are essential to protect privacy.
Correct answer is: Ensuring patient consent for video recording and secure storage
Q.104 Which of the following is a primary function of a Notified Body in the EU medical device regulatory system?
Conducting market research
Assessing conformity of devices with the MDR and granting CE marking
Providing legal representation for manufacturers
Setting pricing guidelines for devices
Explanation - Notified Bodies perform conformity assessments required for CE marking under the MDR.
Correct answer is: Assessing conformity of devices with the MDR and granting CE marking
Q.105 When a rehabilitation engineer includes a feature that allows remote adjustment of device parameters by a clinician, the key ethical concern is:
Device weight
Potential unauthorized access and patient safety
Color of the device
Battery charging time
Explanation - Remote control introduces cybersecurity risks that must be mitigated to protect patients.
Correct answer is: Potential unauthorized access and patient safety
Q.106 Which ethical principle is most directly related to the requirement for manufacturers to report adverse events to regulatory agencies?
Justice
Beneficence
Non‑maleficence
Autonomy
Explanation - Reporting adverse events helps prevent further harm, aligning with the duty to avoid causing harm.
Correct answer is: Non‑maleficence
Q.107 A rehabilitation device is designed with a proprietary algorithm that adapts to user gait. To comply with transparency standards, the engineer should:
Keep the algorithm secret to maintain competitive advantage
Provide a clear description of how the algorithm works and its limitations to users and clinicians
Only disclose the algorithm to the regulator
Publish the full source code online
Explanation - Transparency about functionality and limits supports informed decision‑making while protecting intellectual property.
Correct answer is: Provide a clear description of how the algorithm works and its limitations to users and clinicians
Q.108 Which of the following best exemplifies the concept of "informed refusal"?
A patient declines a recommended prosthetic after being fully informed of its risks and benefits
A patient signs a consent form without reading it
A clinician decides without consulting the patient
A family member overrides the patient’s decision
Explanation - Informed refusal respects autonomy by allowing a patient to decline after understanding the information.
Correct answer is: A patient declines a recommended prosthetic after being fully informed of its risks and benefits
Q.109 A rehabilitation engineering firm wants to test a new device on a vulnerable population (e.g., cognitively impaired adults). The most important ethical safeguard is:
Providing a higher payment to participants
Obtaining consent from a legally authorized representative and ensuring minimal risk
Skipping the IRB review because the study is low‑cost
Allowing participants to self‑select without oversight
Explanation - Vulnerable populations require additional protections, including surrogate consent and risk minimization.
Correct answer is: Obtaining consent from a legally authorized representative and ensuring minimal risk
Q.110 Which of the following standards addresses the safety and performance of active implantable medical devices (AIMDs) like neuroprostheses?
IEC 60601-1-8
ISO 14971
IEC 60601-1-2
ISO 13485
Explanation - IEC 60601‑1‑8 deals specifically with the alarm systems and safety of active implantable devices.
Correct answer is: IEC 60601-1-8
Q.111 When a rehabilitation engineer incorporates user feedback from a focus group into device design, this practice aligns with which ethical principle?
Beneficence
Autonomy
Justice
Non‑maleficence
Explanation - Incorporating user feedback improves device usefulness and well‑being, reflecting beneficence.
Correct answer is: Beneficence
Q.112 A rehabilitation engineer must decide whether to release a device that shows marginal efficacy but significant cost savings. The most appropriate ethical framework to guide this decision is:
Cost‑benefit analysis alone
Risk‑benefit analysis incorporating patient outcomes and equity considerations
Marketing potential analysis
Personal preference of the engineer
Explanation - A comprehensive risk‑benefit analysis balances efficacy, safety, cost, and fairness.
Correct answer is: Risk‑benefit analysis incorporating patient outcomes and equity considerations