Applied ISO14971 Medical Device Risk Management

🚀 Course Title: Applied ISO14971 Medical Device Risk Management 🎓 Headline: A Concise Guide to Executing ISO 14971 Requirements

Course Description: Dive into the world of medical device risk management with our comprehensive, yet concise, 2.4-hour online course. Based on the widely recognized ISO 14971:2007 standard, this course is meticulously designed to equip you with a thorough understanding of risk management within the medical device industry. Whether you're a novice or looking to supplement your knowledge alongside the comprehensive 80-page standard, this course is tailored to guide you through the complexities of ISO 14971.

🔍 Key Focus Areas:

• Foundation in ISO 14971 Principles: Gain a solid grasp of the fundamental principles of ISO 14971, including its scope and application.
• Risk Management Methodologies: Learn about the systematic methodology for risk management, connecting key elements that are crucial for the effective application of ISO 14971.
• Tools Mastery: Develop proficiency with critical tools such as Failure Mode and Effects Analysis (FMEA) and Fault-Tree Analysis (FTA), and understand their practical applications in your risk management projects.
• Risk Profiles and Documentation: Acquire guidelines for conducting efficient meetings and constructing medical device risk profiles, along with the necessary documentation to support your risk management activities.

Why This Course is Essential: ✅ Regulatory Compliance: Risk management is a critical regulatory obligation, essential for assessing the safety of medical devices during design and throughout the product lifecycle. ✅ Continuous Risk Evaluation: Learn how to conduct continuous risk evaluation from design input through production to post-production, ensuring safety and compliance at every stage. ✅ Business Approach: This course adopts a business perspective, integrating project management techniques to foster support and commitment across your organization for ISO 14971 compliance.

A Methodical Approach to Understanding ISO14971: This course is structured to provide you with an organized approach to understanding and applying the principles of ISO 14971. You'll learn through practical examples and workshops, ensuring that you can confidently apply these methodologies in real-world scenarios.

Course Materials & Resources: Upon enrollment, you will gain access to a suite of valuable resources to support your learning journey:

• 7 Practice Workshops: Engage with interactive workshops designed to reinforce your understanding of the concepts.
• Risk Management Plan Template: Utilize a ready-to-use template to help structure your risk management plan effectively.
• Quantitative Risk/Benefit Analysis Technical Report: Learn how to document your findings with our comprehensive technical report guide.
• FMEA Worksheet in MS Excel Format: Get hands-on experience with an FMEA worksheet that you can use immediately in your projects.
• AAMI White Paper: Risk Principles and Medical Devices: Gain insights from the Association for Advancement of Medical Instrumentation (AAMI) on best practices for risk management in medical devices.

Embark on your journey to mastering medical device risk management with our Applied ISO 14971 course. Whether you're a quality assurance professional, an engineer, or part of the regulatory team, this course will provide you with the skills and knowledge necessary to meet the requirements of ISO 14971 and ensure the safety and efficacy of medical devices. Enroll now to elevate your expertise in risk management! 🎓✨