ISO 13485 and CDSCO guidance MCQs With Answer

ISO 13485 and CDSCO Guidance MCQs With Answer

This quiz set is designed for M.Pharm students to deepen understanding of ISO 13485 quality management requirements and relevant CDSCO (Central Drugs Standard Control Organization) guidance for medical devices in India. The questions focus on QMS structure, risk management integration (ISO 14971), design and process validation, supplier control, post-market surveillance, classification and regulatory expectations under Indian medical device rules. These MCQs include clear answers and targeted scenarios to help you prepare for exams and practical regulatory responsibilities in industry. Work through the questions to reinforce key concepts and identify areas for further study in regulatory compliance for medical devices.

Q1. What is the primary objective of ISO 13485:2016 for medical device manufacturers?

• To provide detailed clinical trial protocols for medical devices
• To establish a quality management system that consistently meets regulatory and customer requirements for medical devices
• To replace all national regulations for medical devices
• To define pricing strategies for medical device markets

Correct Answer: To establish a quality management system that consistently meets regulatory and customer requirements for medical devices

Q2. Which standard is most commonly used to address risk management for medical devices alongside ISO 13485?

• ISO 9001
• ISO 14971
• IEC 60601
• ISO 14001

Correct Answer: ISO 14971

Q3. Under ISO 13485, which activity is explicitly required to demonstrate control of production and service provision?

• Annual marketing analysis
• Validation of processes where the resulting output cannot be verified by subsequent monitoring or measurement
• External benchmarking against competitors
• Mandatory publication of device design files

Correct Answer: Validation of processes where the resulting output cannot be verified by subsequent monitoring or measurement

Q4. Which clause of ISO 13485 emphasizes the need for documented procedures for control of nonconforming product?

• Management Responsibility
• Resource Management
• Measurement, Analysis and Improvement
• Product Realization

Correct Answer: Measurement, Analysis and Improvement

Q5. In CDSCO/Indian Medical Device Rules, which class corresponds to the highest risk devices?

• Class A
• Class B
• Class C
• Class D

Correct Answer: Class D

Q6. Which activity is a key element of post-market surveillance expected by CDSCO and ISO 13485?

• Only pre-market clinical testing
• Active monitoring of performance and reporting of adverse events for continuous safety assessment
• Annual sales forecasting
• Confidential internal benchmarking without external reporting

Correct Answer: Active monitoring of performance and reporting of adverse events for continuous safety assessment

Q7. Which documentation is central to demonstrating device design control and technical justification during CDSCO review?

• Technical File or Design Dossier containing design outputs, verification and validation evidence
• Only marketing brochures
• Generic ISO 9001 certificate without device-specific data
• Employee resumes

Correct Answer: Technical File or Design Dossier containing design outputs, verification and validation evidence

Q8. What is the purpose of supplier evaluation and control under ISO 13485?

• To increase the number of suppliers regardless of quality
• To ensure that purchased products and services conform to specified requirements and maintain device safety and performance
• To delegate all regulatory responsibilities to suppliers
• To reduce documentation by avoiding supplier records

Correct Answer: To ensure that purchased products and services conform to specified requirements and maintain device safety and performance

Q9. Which process is crucial for sterile medical devices and is specifically emphasized in ISO 13485 requirements?

• Color matching of packaging
• Validation of sterilization processes and maintenance of sterile barrier systems
• Daily social media updates
• Routine marketing surveys

Correct Answer: Validation of sterilization processes and maintenance of sterile barrier systems

Q10. What role does management review play in an ISO 13485 QMS?

• To replace internal audits
• To ensure top management periodically evaluates the QMS for suitability, adequacy and effectiveness and drives continual improvement
• To conduct product testing
• To create marketing strategies

Correct Answer: To ensure top management periodically evaluates the QMS for suitability, adequacy and effectiveness and drives continual improvement

Q11. Which activity is a required element of CAPA (Corrective and Preventive Action) per ISO 13485?

• Ignoring minor complaints to save resources
• Investigation of root causes, implementation of corrective actions, and verification of effectiveness
• Only documenting the complaint without action
• Outsourcing CAPA entirely to a marketing firm

Correct Answer: Investigation of root causes, implementation of corrective actions, and verification of effectiveness

Q12. For regulatory submissions to CDSCO, why is traceability important in the QMS documentation?

• It allows manufacturers to track materials, components and finished devices back to suppliers and forward to customers to support recalls and investigations
• It is used mainly for marketing analytics
• It ensures faster shipping of products
• It reduces the need for training

Correct Answer: It allows manufacturers to track materials, components and finished devices back to suppliers and forward to customers to support recalls and investigations

Q13. Which requirement demonstrates that a manufacturer has implemented design validation?

• Evidence showing the device meets user needs and intended use under actual or simulated use conditions
• Only a one-line statement claiming validation was done
• Publishing device images online
• Annual profit reports

Correct Answer: Evidence showing the device meets user needs and intended use under actual or simulated use conditions

Q14. Which term best describes the CDSCO expectation for clinical data for medium to high-risk devices?

• Clinical evidence proportional to risk and sufficient to demonstrate safety and performance
• No clinical data is ever needed
• Only literature from unrelated devices
• Marketing claims without data

Correct Answer: Clinical evidence proportional to risk and sufficient to demonstrate safety and performance

Q15. When is device-specific ISO 13485 certification typically accepted by regulators like CDSCO as part of conformity assessment?

• When the certificate is relevant, current, and issued by an accredited/recognized certification body and aligns with regulatory requirements
• When it is expired
• When issued by a random consulting firm without accreditation
• When only claimed verbally by the manufacturer

Correct Answer: When the certificate is relevant, current, and issued by an accredited/recognized certification body and aligns with regulatory requirements

Q16. Which action best reflects effective change control under ISO 13485?

• Implementing design or process changes without documentation to speed up production
• Documenting, evaluating, approving and verifying changes prior to implementation to ensure continued conformity and traceability
• Only notifying marketing after change is made
• Using verbal approvals from production staff

Correct Answer: Documenting, evaluating, approving and verifying changes prior to implementation to ensure continued conformity and traceability

Q17. Which element is commonly required by CDSCO for imported medical devices?

• Proof of conformity to applicable standards, registration/clearance documents and import/manufacturing licence as per Indian regulations
• The manufacturer’s internal sales targets
• Only a local distributor’s brochure
• Evidence of export volume to other countries only

Correct Answer: Proof of conformity to applicable standards, registration/clearance documents and import/manufacturing licence as per Indian regulations

Q18. What is the expected outcome of internal audits within an ISO 13485 QMS?

• To identify nonconformities, opportunities for improvement and verify that processes are effectively implemented and maintained
• To exclusively promote staff without review
• To reduce documentation by eliminating records
• To replace management responsibility

Correct Answer: To identify nonconformities, opportunities for improvement and verify that processes are effectively implemented and maintained

Q19. How should a manufacturer respond to a serious adverse event reported in the field according to CDSCO expectations?

• Ignore the report if sales are high
• Initiate investigation, notify competent authorities as required, take appropriate corrective actions, and update risk assessment and labeling if necessary
• Only inform marketing to issue a press release
• Wait for multiple complaints before taking any action

Correct Answer: Initiate investigation, notify competent authorities as required, take appropriate corrective actions, and update risk assessment and labeling if necessary

Q20. Which of the following best describes the relationship between ISO 13485 documentation and regulatory submissions to CDSCO?

• ISO 13485 documentation is irrelevant to regulatory submissions
• Comprehensive QMS documentation provides supporting evidence of consistent processes, design control, risk management, and post-market activities required for regulatory assessment
• Only financial reports are needed for regulatory approval
• Regulatory submissions require only marketing materials

Correct Answer: Comprehensive QMS documentation provides supporting evidence of consistent processes, design control, risk management, and post-market activities required for regulatory assessment

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