Course description
ISO 14971:2019 is the internationally recognized standard for risk management in medical devices. This is a one day course which provides a comprehensive understanding of the principles, requirements, and best practices outlined in ISO 14971:2019. Participants will learn how to effectively apply risk management processes throughout the lifecycle of medical devices, ensuring compliance with regulatory requirements and enhancing patient safety.
Benefits:
- Enhance competency in risk management practices specific to medical devices.
- Ensure compliance with international standards and regulatory requirements.
- Improve product safety and reliability through effective risk assessment and control.
- Gain insights into industry best practices and case studies for practical application.
Upcoming start dates
Suitability - Who should attend?
Who Should Attend:
- Medical device manufacturers, regulatory affairs professionals, quality assurance managers, and engineers involved in product development and lifecycle management.
- Professionals responsible for risk management, compliance, and safety within medical device companies.
- Consultants and auditors seeking to expand their expertise in medical device risk management.
Outcome / Qualification etc.
Course Objectives:
- Gain a thorough understanding of the ISO 14971:2019 standard and its application in the medical device industry.
- Learn to identify, evaluate, and mitigate risks associated with medical devices.
- Understand the relationship between risk management and regulatory compliance.
- Develop skills in risk assessment methodologies, including risk analysis and risk evaluation.
- Acquire knowledge of risk control measures and risk management documentation requirements.
- Explore case studies and practical examples to illustrate effective risk management strategies.
Certification:
Participants will receive a certificate of completion upon successfully fulfilling the course requirements, demonstrating their understanding and application of ISO 14971:2019 principles.
Training Course Content
Course Topics:
- Introduction to ISO 14971:2019 and its significance in medical device risk management.
- Risk management principles and framework according to ISO 14971:2019.
- Risk management planning and implementation.
- Risk analysis techniques: Hazard identification, risk estimation, and risk evaluation.
- Risk control measures and mitigation strategies.
- Risk management throughout the medical device lifecycle: Design, manufacturing, and post-market phases.
- Documentation requirements and traceability in risk management.
Course delivery details
Course Format:
- Duration: [Specify duration, e.g., 2 days]
- Delivery: Instructor-led training, either in-person or virtual sessions.
- Interactive sessions, workshops, and discussions to reinforce learning.
- Comprehensive course materials and resources provided to participants.
Expenses
Class Size and price: Up to 15 delegates £2,225.00
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