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Corporate Training for Teams

ISO 14971:2019 Risk Analysis For Medical Devices

Spade Learning Academy, Online (+1 locations)
Length
1 day
Next course start
Please enquire for course dates (+2 start dates)
Course delivery
Virtual Classroom, In Company
Length
1 day
Next course start
Please enquire for course dates (+2 start dates)
Course delivery
Virtual Classroom, In Company

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

Choose between 2 start dates

Please enquire for course dates

  • In Company
  • United Kingdom
  • English

Please enquire for course dates

  • Virtual Classroom
  • Online
  • English

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:


  1. Introduction to ISO 14971:2019 and its significance in medical device risk management.
  2. Risk management principles and framework according to ISO 14971:2019.
  3. Risk management planning and implementation.
  4. Risk analysis techniques: Hazard identification, risk estimation, and risk evaluation.
  5. Risk control measures and mitigation strategies.
  6. Risk management throughout the medical device lifecycle: Design, manufacturing, and post-market phases.
  7. 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

Spade Learning Academy
71-75 Shelton St, Covent Garden
WC2H 9JQ London

Spade Learning Academy

At our academy, we believe that education and further training is a lifelong journey. We are committed to helping our students succeed in their academic and professional endeavors. Whether you are a seasoned professional looking to advance your career or...

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