The OSHAA 30-Hours ISO 14971:2019 – Risk Management Application on Medical Devices Lead Auditor programme is designed for professionals seeking practical knowledge of medical device risk management, ISO 14971:2019 requirements and risk-based auditing principles. It provides a structured understanding of how organisations can identify, evaluate, control and monitor risks associated with medical devices throughout their lifecycle.
ISO 14971:2019 establishes a systematic approach to managing risks related to medical devices, helping manufacturers consider hazards, hazardous situations, foreseeable misuse and potential harm. Effective risk management is essential for supporting medical device safety, performance, regulatory compliance and informed decision-making.
The programme explores important areas including risk management planning, hazard identification, risk analysis, risk evaluation, risk control, residual risk, benefit-risk analysis, risk management documentation and production and post-production information. Learners also develop awareness of audit planning, objective evidence, audit findings, nonconformities and corrective actions within a medical device risk management environment.
This training is relevant to medical device manufacturers, QA/QC professionals, regulatory affairs specialists, quality managers, risk management professionals, auditors, engineers and compliance personnel.
By developing knowledge of ISO 14971:2019 and risk-based auditing, the programme helps professionals contribute to robust medical device risk management processes and support organisations in maintaining effective controls across the medical device lifecycle.
All About OSHAA 30-Hours ISO 14971:2019 – Risk Management Application on Medical Devices Lead Auditor
Course Overview
The OSHAA 30-Hours ISO 14971:2019 – Risk Management Application on Medical Devices Lead Auditor is a specialised professional training programme focused on medical device risk management, ISO 14971:2019 requirements and lead auditing principles.
The course consists of 8 units, providing structured learning across the key stages of the medical device risk management process and the auditing activities used to evaluate its effective implementation.
Learners explore how to establish and maintain a risk management process covering risk management planning, hazard identification, risk analysis, risk evaluation, risk control and residual risk assessment. The programme also addresses benefit-risk analysis and the importance of monitoring information throughout the medical device lifecycle.
The auditing component develops knowledge of audit planning, audit criteria, objective evidence, audit interviews, audit findings, nonconformities, corrective actions and audit reporting. Learners gain an understanding of how audit evidence can be evaluated against relevant ISO 14971:2019 requirements.
The programme is relevant to medical device quality professionals, regulatory affairs personnel, QA/QC specialists, risk management professionals, auditors, engineers, compliance officers and medical device manufacturers.
By combining ISO 14971:2019 risk management knowledge with lead auditor principles, the course helps Learners understand how effective risk processes can be evaluated, documented and improved to support medical device safety, regulatory compliance and lifecycle risk management.
Entry Requirement:
The OSHAA 30-Hours ISO 14971:2019 programme is suitable for professionals and Learners interested in medical device risk management and quality systems.
- Age: Normally 18 years or above.
- Experience: Medical device, QA/QC, auditing or regulatory experience is beneficial but not essential.
- Educational Background: A background in medical devices, engineering, healthcare, quality or a related field is recommended.
- Language Proficiency: Basic English language skills are required to understand technical content and complete assessments.
- Technical Knowledge: Basic awareness of quality management or risk management is helpful but not mandatory.
Study Units
The programme covers the following key study units:
- Introduction to ISO 14971:2019 – Risk Management for Medical Devices (3 Hours)
- Risk Management Process Overview and Terminology (4 Hours)
- Risk Analysis: Identifying Hazards and Assessing Risks (5 Hours)
- Risk Control Measures and Mitigation Strategies (4 Hours)
- Auditing Risk Management Systems for Compliance (5 Hours)
- Documentation Requirements and Record Keeping in Risk Management (4 Hours)
- Corrective Actions and Risk Management Audits (3 Hours)
- Continual Improvement and Monitoring of Risk Management Systems (2 Hours)
Learning Outcomes:
By the end of this course, learners will be able to:
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.
Ideal Candidate:
The OSHAA 30-Hours ISO 14971:2019 programme is designed for professionals seeking practical knowledge of medical device risk management and risk-based auditing.
- Medical Device Professionals: Personnel involved in medical device development and manufacturing.
- QA/QC Professionals: Quality specialists managing medical device quality and compliance.
- Risk Management Professionals: Personnel responsible for identifying and controlling product risks.
- Regulatory Affairs Staff: Professionals supporting medical device regulatory requirements.
- Quality Managers: Managers overseeing quality systems and risk management activities.
- Internal Auditors: Professionals involved in auditing risk management processes.
- Lead Auditor Aspirants: Learners seeking knowledge of medical device risk-based auditing.
- Medical Device Engineers: Engineers involved in product safety, design and technical compliance.
- Compliance Professionals: Personnel supporting regulatory and quality compliance.
- Consultants: Professionals advising organisations on medical device risk management and quality systems.
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