Regulatory Affairs Consultant Interview Questions and Answers

ISO 14971 is a standard for risk management in medical devices. A typical risk management report includes hazard identification, risk analysis, risk evaluation, and risk control measures.

• ISO 14971 is a standard for risk management in medical devices

• A typical risk management report includes hazard identification, risk analysis, risk evaluation, and risk control measures

• The report should also include a risk-benefit analysis and a residual risk assessment

• An example of a risk man...read more

ISO 13485 has 10 clauses covering quality management systems for medical devices.

• Clause 4: Quality management system

• Clause 5: Management responsibility

• Clause 6: Resource management

• Clause 7: Product realization

• Clause 8: Measurement, analysis and improvement

• Clause 9: Risk management

• Clause 10: Technical documentation

• Clause 11: Clinical evaluation

• Clause 12: Vigilance and post-market surveillance

• Clause 13: Regulatory compliance

EU MDR and FDA are regulatory requirements for medical devices.

• EU MDR (Medical Device Regulation) is a new regulation that replaces the Medical Device Directive (MDD) and the Active Implantable Medical Device Directive (AIMDD). It applies to all medical devices sold in the European Union.

• FDA (Food and Drug Administration) is a regulatory agency in the United States that is responsible for ensuring the safety and efficacy of medical devices sold in the US market.

• Both EU MDR an...read more

SDLC is a process for developing software while IEC 62304 is a standard for medical device software development.

• SDLC stands for Software Development Life Cycle and includes phases like planning, design, testing, and maintenance.

• IEC 62304 is a standard for medical device software development that outlines requirements for software development processes, documentation, and risk management.

• IEC 62304 requires software developers to follow a rigorous process for developing medical...read more