Learning Outcomes for the Study Units:

Introduction to ISO 14971:2019

• Understand the purpose and scope of ISO 14971:2019.
• Familiarize with key concepts and terminology related to risk management for medical devices.
• Recognize the significance of ISO 14971 compliance in ensuring the safety and effectiveness of medical devices.

Fundamentals of Risk Management

• Describe the principles and processes involved in risk management.
• Identify hazards associated with medical devices and assess their potential risks.
• Demonstrate proficiency in risk assessment, control, evaluation, and review according to ISO 14971 guidelines.

Risk Management in Medical Devices

• Analyze the unique challenges and considerations in managing risks specific to medical devices.
• Interpret regulatory requirements and industry best practices related to risk management in the medical device sector.
• Apply risk management principles to address safety, performance, and usability concerns in the design and development of medical devices.

ISO Internal Auditing Principles

• Explain the role and importance of internal auditing in ensuring compliance with ISO standards.
• Demonstrate knowledge of auditing principles, techniques, and methodologies.
• Develop skills in audit planning, conducting audits, and reporting findings in alignment with ISO requirements.

ISO 14971 Implementation

• Develop strategies for implementing ISO 14971 within an organization.
• Establish risk management processes, documentation requirements, and integration with quality management systems.
• Assess the effectiveness of risk management implementation through monitoring and review mechanisms.

Risk Analysis Techniques

• Identify and apply various risk analysis techniques used in the medical device industry, such as fault tree analysis and FMEA.
• Interpret and prioritize risks based on severity, occurrence, and detectability.
• Utilize risk analysis results to inform decision-making and risk mitigation strategies.

ISO 14971 Documentation Requirements

• Understand the documentation requirements specified by ISO 14971.
• Develop comprehensive risk management plans, files, and reports in compliance with ISO standards.
• Ensure accuracy, completeness, and traceability of risk management documentation throughout the product lifecycle.

Role of the ISO Internal Auditor

• Define the roles and responsibilities of ISO internal auditors within an organization.
• Conduct audits effectively, including planning, executing, and reporting audit findings.
• Collaborate with stakeholders to implement corrective actions and drive continuous improvement in risk management processes.

Regulatory Compliance and Standards

• Interpret and comply with regulatory requirements governing medical devices, including FDA regulations and EU Medical Device Regulation.
• Stay informed about international standards relevant to medical device risk management, such as ISO 13485.
• Implement processes to ensure ongoing regulatory compliance and adherence to industry standards.

Continuous Improvement in Risk Management

• Identify opportunities for improvement in risk management processes and practices.
• Implement feedback mechanisms and lessons learned to enhance risk management effectiveness.
• Foster a culture of continuous improvement within the organization to adapt to evolving regulatory requirements and industry best practices.

Ethical Considerations in Risk Management

• Recognize ethical issues and dilemmas relevant to risk management in the medical device industry.
• Apply ethical principles, including patient safety, transparency, and integrity, to risk management decision-making.
• Promote ethical behavior and practices among stakeholders to uphold the highest standards of integrity and professionalism in risk management.