The medical device industry plays a critical role in healthcare, where the safety and effectiveness of products can directly impact patients’ lives. Therefore, adhering to global standards for risk management is paramount. The OSHAA 30-Hours ISO 14971:2019 – Risk Management Application on Medical Devices Lead Auditor course is specifically designed to train professionals in the latest ISO 14971:2019 standard, empowering them to become expert lead auditors in the field of medical device risk management.
ISO 14971:2019 is the internationally recognised standard for risk management in medical device manufacturing. It outlines the process of identifying, evaluating, and mitigating risks associated with medical devices, ensuring the safety of patients and users. Adopting this standard is essential for manufacturers seeking to comply with regulatory requirements, enhance product quality, and maintain consumer trust.
The OSHAA 30-Hours ISO 14971:2019 – Risk Management Application on Medical Devices Lead Auditor course is an essential training for professionals in the medical device industry. Whether you are a quality assurance expert, lead auditor, or regulatory affairs professional, this course provides the in-depth knowledge and practical skills necessary to effectively manage risks associated with medical devices. By mastering ISO 14971:2019, you can ensure compliance with regulatory standards, contribute to product safety, and enhance your career in the growing field of medical device risk management.
OSHAA 30-Hours ISO 14971:2019 – Risk Management Application on Medical Devices Lead Auditor
Study Units
Learning Outcomes
Introduction to ISO 14971:2019 – Risk Management for Medical Devices (3 Hours)
- Understand the purpose and scope of ISO 14971:2019 for medical device risk management.
- Recognise the key principles of risk management within the context of medical devices.
- Gain an overview of the risk management process as it applies to medical device development and lifecycle.
- Learn the importance of compliance with ISO 14971:2019 for ensuring patient safety and device efficacy.
Risk Management Process Overview and Terminology (4 Hours)
- Familiarise with the risk management process as outlined in ISO 14971:2019.
- Understand the terminology and definitions used in medical device risk management.
- Learn how to apply the risk management process across the device lifecycle, from design to post-market activities.
- Gain knowledge of key concepts such as risk assessment, risk control, and monitoring.
Risk Analysis: Identifying Hazards and Assessing Risks (5 Hours)
- Develop skills in identifying potential hazards associated with medical devices.
- Learn how to assess risks based on severity and probability.
- Understand various risk analysis techniques used in the medical device industry.
- Gain knowledge in evaluating risks related to device functionality, user safety, and environmental factors.
Risk Control Measures and Mitigation Strategies (4 Hours)
- Learn how to identify and evaluate appropriate risk control measures for mitigating identified risks.
- Understand the hierarchy of risk control measures and their implementation in the design and development of medical devices.
- Develop strategies for reducing or eliminating risks through design changes, warnings, or protective measures.
- Gain insight into how to balance risk reduction efforts with the device’s intended performance.
Auditing Risk Management Systems for Compliance (5 Hours)
- Understand the role of auditing in ensuring compliance with ISO 14971:2019.
- Learn how to audit risk management systems effectively and identify gaps in compliance.
- Develop auditing techniques to assess risk management processes, including hazard identification and risk control measures.
- Gain practical experience in performing audits of medical device risk management systems and reporting findings.
Documentation Requirements and Record Keeping in Risk Management (4 Hours)
- Understand the critical importance of documentation in risk management processes.
- Learn the key documentation requirements outlined in ISO 14971:2019 for medical devices.
- Develop skills in reviewing and assessing the quality and completeness of risk management documentation.
- Gain an understanding of the types of records necessary to demonstrate compliance with risk management standards.
Corrective Actions and Risk Management Audits (3 Hours)
- Learn how to identify non-compliance or deficiencies in risk management systems.
- Understand the process for implementing corrective actions to address audit findings.
- Develop skills in designing and tracking corrective actions and ensuring they are effectively integrated into the risk management system.
- Gain knowledge of best practices for ensuring corrective actions contribute to ongoing system improvement.
Continual Improvement and Monitoring of Risk Management Systems (2 Hours)
- Understand the principles of continual improvement in risk management processes.
- Learn how to monitor the effectiveness of risk controls and their ongoing suitability.
- Gain insight into how to evaluate risk management systems post-market and incorporate feedback for improvement.
- Develop strategies for continuously enhancing risk management practices and achieving long-term safety and compliance.
- Expert Knowledge of ISO 14971:2019
Gain a deep understanding of the ISO 14971:2019 standard and how it applies to the risk management process for medical devices, ensuring you are well-versed in best practices for ensuring patient safety and regulatory compliance. - Enhanced Auditing Skills
Learn effective auditing techniques specific to risk management systems for medical devices, helping you identify non-compliance, assess risk management processes, and ensure that systems meet the rigorous standards required by regulatory bodies. - Compliance with Regulatory Standards
Master the requirements of ISO 14971:2019 and learn how to ensure that medical device manufacturers comply with both national and international risk management regulations, reducing the risk of product recalls and non-compliance penalties. - Improved Risk Mitigation and Control
Acquire the knowledge to identify, assess, and mitigate potential risks throughout the lifecycle of medical devices. Understand how to design and implement risk control strategies to enhance patient safety and minimise harm. - Increased Career Opportunities
By completing this accredited course, you will enhance your qualifications, opening up a range of career opportunities in quality assurance, regulatory affairs, and auditing within the medical device industry. - Hands-On Practical Application
The course includes practical examples and case studies, providing real-world experience in auditing risk management systems. This practical approach ensures you can apply your knowledge immediately in your workplace. - Improved Documentation and Record-Keeping
Understand the importance of accurate documentation and record-keeping in risk management, ensuring that you can create, review, and manage compliance-related documents effectively and efficiently. - Ability to Implement Continual Improvement
Learn strategies for continually improving risk management systems, ensuring long-term safety, quality, and compliance within the medical device industry. Monitor and adapt systems post-market to ensure ongoing effectiveness. - Boosted Confidence in Auditing
With the knowledge gained from the course, you will be more confident in conducting audits, offering expert guidance on identifying potential risks and recommending necessary improvements to risk management processes. - Global Recognition
The training is internationally recognised, providing you with a certification that boosts your credibility and opens doors for opportunities in global markets, particularly within regulatory bodies, medical device manufacturers, and auditing firms.
By completing the OSHAA 30-Hours ISO 14971:2019 Lead Auditor course, you will become a highly skilled professional capable of managing risk and ensuring compliance in the critical medical device industry.
- Lead Auditors and Quality Assurance Professionals
This course is ideal for lead auditors, quality managers, and professionals working in regulatory affairs who are responsible for ensuring compliance with risk management standards in the medical device industry. - Medical Device Manufacturers and Engineers
Individuals working in the design, development, and manufacturing of medical devices will benefit from this course by gaining essential knowledge of risk management principles to ensure product safety and regulatory compliance. - Regulatory Affairs Specialists
Professionals in regulatory affairs will find this course valuable for understanding ISO 14971:2019 and learning how to integrate risk management requirements into the product lifecycle to meet regulatory expectations. - Compliance Officers and Risk Managers
This course is beneficial for those involved in overseeing the risk management processes within medical device companies, ensuring that risk is appropriately managed and that compliance is maintained. - Consultants in the Medical Device Industry
Healthcare consultants and experts advising medical device manufacturers or healthcare organisations on risk management will gain deeper insights into auditing and applying ISO 14971:2019 effectively. - Medical Device Regulatory Inspectors
Regulatory inspectors and professionals working in governmental or certification bodies responsible for medical device regulation can enhance their auditing skills and gain a deeper understanding of risk management compliance. - Healthcare Professionals Involved in Medical Device Safety
Healthcare practitioners who are involved in the evaluation, purchase, or use of medical devices, as well as those in safety-critical roles, will benefit from understanding how risk management frameworks are applied to ensure the safety of the devices used in clinical settings.
This course is perfect for anyone who wants to develop expertise in auditing and managing risk within the medical device sector, ensuring compliance with ISO 14971:2019 and enhancing product safety.
