I read another article on risk management and it mentions other errors: 1) Lack of integration: silos between risk management and development 2) Understand and incorporate “intended use” in your risk management process 3) Failing to conduct and document risk-related activities in real time 4) Failing to document design controls or DHF 5) delaying implementing your quality management system. There are so many risk in medical device from start to finish so it’s best to analyze risk at every step.