ANSI/AAMI HE75:2009 (R2018) – Human Factors Engineering: Design of Medical Devices Training by Tonex is a comprehensive course designed for professionals involved in the design, development, and usability of medical devices.
This training dives deep into the ANSI/AAMI HE75 standard, providing actionable insights to optimize user-centric designs, ensure compliance, and improve patient safety. Through interactive sessions, case studies, and practical applications, participants gain the knowledge needed to implement human factors engineering effectively.
- Understand the key principles of ANSI/AAMI HE75:2009 (R2018) and its impact on medical device design.
- Explore the importance of human factors engineering in enhancing usability and safety.
- Learn to identify and mitigate usability risks during the design and development process.
- Gain insights into regulatory expectations and compliance strategies for medical device design.
- Master techniques for conducting usability testing and applying feedback to design iterations.
- Discover best practices for creating intuitive, accessible, and patient-centered medical devices.
- Expert Guidance: Learn from Tonex’s seasoned instructors with industry experience.
- Comprehensive Coverage: Gain in-depth knowledge of ANSI/AAMI HE75 principles and applications.
- Hands-On Learning: Engage in practical exercises to apply concepts in real-world scenarios.
- Regulatory Insights: Stay ahead in compliance with evolving FDA and international guidelines.
- Network Building: Connect with peers and industry professionals to exchange ideas and experiences.
- Proficiency in applying human factors engineering to medical device design.
- Ability to perform usability testing and risk analysis effectively.
- Understanding of regulatory standards related to medical device usability.
- Enhanced skills in creating user-centered design solutions.
- Knowledge of integrating human factors engineering into product lifecycle management.
This course is ideal for:
- Medical device designers and developers
- Usability engineers
- Regulatory affairs professionals
- Quality assurance managers
- Risk management professionals
- Healthcare technology consultants
- Product managers in the medical device sector
- Module 1: Introduction to ANSI/AAMI HE75:2009 (R2018)
- Module 2: Understanding User Needs and Context
- Module 3: Principles of Human Factors Engineering
- Module 4: Human Factors in Risk Management
- Module 5: User Interface Design
- Module 6: Usability Testing and Validation
- Module 7: Documentation and Compliance
- Module 8: Workshop and Certification
Elevate Your Expertise in Medical Device Design! Join Tonex’s ANSI/AAMI HE75:2009 (R2018) training and lead the way in creating safe, effective, and user-friendly medical devices. Register now to secure your spot!
