ISO 14971:2019: Different Perspectives of a Risk Management Program
Description:
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.
Curriculum for this course:
Program Introduction
Overview | 1 min 01 secs |
Learning Objectives | 1 min 31 secs |
Who Will Benefit from This Training? | 1 min 21 secs |
Materials Used | 1 min 10 secs |
Program Overview | 1 mins 11 secs |
Course Introduction | 1 min 09 secs |
Course Introduction
Learning Objectives | 1 mins 22 secs |
Setting the Scene | 1 mins 01 secs |
Setting the Scene
Design FMEA – Part 1 | 1 min 12 secs |
Design FMEA – Part 2 | 1 mins 29 secs |
Design FMEA – Part 3 | 1 min 05 secs |
Design FMEA – Part 4 | 50 secs |
Useability Engineering and Use FMEA – Part 1 | 1 min 07 secs |
Useability Engineering and Use FMEA – Part 2 | 1 min |
Useability Engineering and Use FMEA – Part 3 | 1 min 30 secs |
Software
IEC 62304 | 58 secs |
IEC 60601-01(14) | 1 min 20 secs |
SOUP | 1 min 01secs |
Cybersecurity
Cybersecurity – Part 1 | 1 min 19 secs |
Cybersecurity – Part 2 | 1 min 02 secs |
Wireless Risk Analysis | 1 min 10 secs |
PFMEA | 1 min 05 secs |
Conclusion
Final Exam
Certification
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