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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