1SO 14971:2019

ISO 14971:2019: Different Perspectives of a Risk Management Program

In this course we will discuss the different viewpoints. This is not discussed in the standard, but these things are typically done so to give you a true perspective on Risk Management, it’s important to discuss these. It’s important to recognize that risk NEEDS to be viewed through different lenses to ensure a successful program. If we just do a single FMEA, for example, we are likely not considering all aspects that should be considered.

CEU Credits: 0.1
Course Code: ELM-338
Duration: 45 mins
Skill Level: Intermediate
Final Exam: Yes
Certification: Yes
Version: V1.0

Curriculum for this course

Overview
Learning Objectives
Who Will Benefit from This Training?
Materials Used
Program Overview
Course Introduction
Learning Objectives
Setting the Scene
Design FMEA – Part 1
Design FMEA – Part 2
Design FMEA – Part 3
Design FMEA – Part 4
Useability Engineering and Use FMEA – Part 1
Useability Engineering and Use FMEA – Part 2
Useability Engineering and Use FMEA – Part 3
IEC 62304
IEC 60601-01(14)
SOUP
Cybersecurity – Part 1
Cybersecurity – Part 2
Wireless Risk Analysis
PFMEA

Conclusion

Final Exam

Certification