FDA's adoption of ISO 13485 in its Quality Management System Regulation (QMSR) harmonizes quality systems globally for medical devices. AAMI is pleased to support the transition with our new Clause-by-Clause: ISO 13485 eLearning tool. This online course examines each ISO 13485 clause to ensure you fully understand the Standard's implications and requirements. The Clause-by-Clause approach with video instruction by top industry leaders allows you to progress at your own pace. Iterative self-assessment tools strengthen your knowledge and detect and correct misunderstandings.

The Benefits:

1. Stay Ahead of Compliance Requirements: With two years to modify quality systems to meet QMSR and ISO 13485 requirements, our eLearning tool equips you with the knowledge and skills needed to stay ahead of compliance deadlines and navigate regulatory changes.
2. Practical Application: Explore how each clause drives quality in real-world scenarios, utilizing insights from industry professionals and FDA experts.
3. Problem-Solving Strategies: Identify and address common challenges encountered in clause implementation, enhancing preparedness and helping your organization overcome hurdles and ensure a smooth transition.
4. Benchmark for Excellence: Learn best practices associated with each clause, illustrating what excellence in compliance looks like and guiding organizations toward high-performance quality management systems.

This learning assessment tool provides a thorough examination of ISO 14971, aiming to enhance participants' understanding of each clause and its practical implications for identifying, evaluating, and controlling the risks associated with medical devices throughout their lifecycle. The assessment is designed to explore how each clause contributes to driving excellence in practice, offering insights into the tools, procedures, and documentation commonly employed by the industry to meet these requirements.

Learners in this training will be able to:

• Articulate how each clause influences and promotes quality within the medical device lifecycle.
• Provide practical examples of how adherence to the clause enhances the overall quality of the development, manufacturing, and post-market processes.
• Identify the industry-standard tools and procedures utilized to address the specific requirements outlined in each clause.
• Highlight the key documentation and artifacts produced during the implementation of these tools and procedures.
• Explore the challenges faced by the industry in effectively implementing each clause.
• Analyze potential pitfalls and risks associated with non-compliance or incomplete adherence to the specified requirements.
• Offer insights into best practices for successful implementation of each clause.
• Define the characteristics of an exemplary, "great" implementation, showcasing examples from industry leaders.

This learning assessment tool provides a comprehensive view of ISO 14971, going beyond theoretical knowledge to emphasize the practical implications and real-world applications of each clause. By delving into the industry's experiences, challenges, and best practices, participants gain a holistic understanding of the standard's impact on driving quality in the medical device sector while mitigating risk.