Introduction to ISO 14971:2019

1. Understanding of ISO 14971:2019: Gain a comprehensive overview of the purpose, scope, and key principles of ISO 14971:2019.
2. Importance of Risk Management: Recognize the significance of effective risk management in ensuring the safety and efficacy of medical devices.
3. Application of ISO Standards: Learn how ISO 14971:2019 integrates with other ISO standards relevant to medical device risk management.

Risk Management Framework

1. Comprehensive Risk Management Process: Understand the systematic approach outlined in ISO 14971:2019 for identifying, evaluating, and controlling risks throughout the device lifecycle.
2. Steps in Risk Management: Master the stages of risk management planning, risk assessment, risk evaluation, risk control, and monitoring as per the standard.
3. Role in Device Development: Apply the risk management framework from initial design stages through to post-market surveillance.

Risk Analysis Techniques

1. Hazard Identification Methods: Acquire proficiency in various techniques and tools used to identify potential hazards associated with medical devices.
2. Risk Assessment Methods: Learn methodologies for evaluating risks, considering factors such as severity, probability of occurrence, and detectability.
3. Practical Application: Apply risk analysis techniques to case studies and practical scenarios to enhance understanding and decision-making.

Risk Evaluation and Acceptance Criteria

1. Criteria for Risk Acceptance: Define and apply criteria for accepting or mitigating risks based on regulatory requirements and organizational policies.
2. Risk Severity and Probability: Analyze risks based on severity of potential harm to patients or users and the likelihood of occurrence.
3. Decision-Making Process: Develop skills in making informed decisions regarding risk acceptance or further mitigation measures.

Risk Control Measures

1. Risk Reduction Strategies: Implement strategies and controls to minimize identified risks to acceptable levels, considering state-of-the-art technology and best practices.
2. Verification and Validation: Understand the importance of verifying and validating risk control measures to ensure effectiveness and compliance.
3. Continuous Improvement: Evaluate and adjust risk control measures based on ongoing monitoring and feedback from post-market surveillance.

Documentation and Record Keeping

1. Documentation Requirements: Learn the essential components of a risk management file and other documentation necessary to demonstrate compliance with ISO 14971:2019.
2. Record Keeping Practices: Establish effective practices for maintaining accurate records of risk management activities, decisions, and outcomes.
3. Audit and Inspection Preparation: Prepare for audits and inspections by regulatory authorities through comprehensive and well-organized documentation.

Regulatory Compliance

1. Understanding Regulatory Landscape: Gain insight into regulatory requirements applicable to medical devices and their impact on risk management practices.
2. Adherence to Standards: Ensure compliance with ISO 14971:2019 and other relevant international standards, guidelines, and regulations.
3. Risk Management in Regulatory Context: Apply knowledge of regulatory requirements to develop and implement robust risk management strategies that meet compliance standards.

Integration of Risk Management in Device Lifecycle

1. Lifecycle Approach: Integrate risk management principles into the entire lifecycle of medical devices, from concept and design through manufacturing, distribution, and post-market surveillance.
2. Cross-functional Collaboration: Collaborate effectively with multidisciplinary teams to implement and monitor risk management activities across different phases of the device lifecycle.
3. Continuous Improvement: Implement processes for continuous improvement of risk management practices based on feedback, experience, and emerging regulatory requirements.