Course description
The ISO 14971 FRMEA (Failure Modes, Effects, and Criticality Analysis) course is designed to provide participants with a deep understanding of how to effectively integrate Failure Modes, Effects, and Criticality Analysis into the risk management process for medical devices, in accordance with ISO 14971:2019. Over two days, participants will learn the principles, methodologies, and practical applications of FRMEA to enhance product safety, compliance, and overall quality assurance.
Benefits:
- Enhance proficiency in identifying and mitigating potential failure modes in medical devices.
- Improve compliance with international standards and regulatory requirements.
- Strengthen product safety and reliability through systematic risk analysis and prioritization.
- Gain practical skills to effectively implement FRMEA within organizational risk management frameworks.
Upcoming start dates
Suitability - Who should attend?
Who Should Attend:
- Medical device engineers, quality assurance professionals, and regulatory affairs specialists involved in product development and risk management.
- Professionals responsible for implementing and maintaining risk management processes in compliance with ISO 14971:2019.
- Consultants, auditors, and project managers seeking to enhance their expertise in medical device risk analysis and mitigation.
Outcome / Qualification etc.
Course Objectives:
- Understand the fundamentals of ISO 14971:2019 and its application in risk management for medical devices.
- Learn the principles and processes of Failure Modes, Effects, and Criticality Analysis (FMECA).
- Gain proficiency in identifying potential failure modes and their associated effects on medical devices.
- Develop skills in assessing the criticality of failure modes based on severity, occurrence, and detectability.
- Learn how to prioritize and mitigate risks using FRMEA within the medical device lifecycle.
- Understand the integration of FRMEA with other risk management activities and documentation requirements.
- Gain practical insights through case studies and workshops to apply FRMEA effectively.
Certification:
Participants will receive a certificate of completion upon fulfilling the course requirements, demonstrating their understanding and application of ISO 14971 FRMEA principles.
Training Course Content
Day 1:
- Introduction to ISO 14971:2019 and its relevance to risk management in medical devices.
- Overview of Failure Modes, Effects, and Criticality Analysis (FMECA) principles and methodologies.
- Steps for conducting FRMEA: Identification of failure modes, assessment of effects, and criticality analysis.
- Practical exercises: Group workshops to apply FRMEA techniques.
Day 2:
- Risk prioritization and decision-making using FRMEA outcomes.
- Integration of FRMEA with risk control measures and verification activities.
- Documentation and reporting requirements for FRMEA in compliance with ISO 14971.
- Case studies and real-world examples: Application of FRMEA in medical device scenarios.
- Review and assessment: Q&A session, knowledge check, and certification criteria.
Course delivery details
Course Format:
- Duration: Two days (16 hours)
- Delivery: Instructor-led training, available in both in-person and virtual formats.
- Interactive Learning: Hands-on workshops, case studies, and group discussions to reinforce learning.
- Comprehensive Materials: Participants will receive course materials, templates, and resources for future reference.
Expenses
Class Size and price: Up to 15 delegates £3,450.00
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