By Edwin L. Bills, Consultant for Qosina
Boeing has been in the news frequently for two crashes involving the 737 MAX 8 aircraft. One commonality between the 737 MAX 8 aircraft and medical devices is that the company marketing the device is responsible for everything in it, regardless of who created the product. Risk management is a crucial part of any design and development process. There is a series of checks and balances that must be met, and companies must have an established risk management process in place that complies with industry regulations.
See how these two topics relate to one another, what went wrong with the 737 MAX 8 aircraft hardware and software systems, and how we can apply the findings to the medical device industry to ensure that risk controls are properly implemented and verified as effective.