New Qosina white paper stresses importance of proper risk analysis throughout product lifecycle
Qosina has published a white paper, “What Can the Medical Device Industry Learn from the Boeing 737 MAX 8 Crashes?”
Risk management is a crucial part of any design and development process, suggested the company in a media release, noting a series of checks and balances that must be met and that companies must have an established risk management process in place that complies with industry regulations.
In the case of the two recent 737 MAX 8 plane crashes, they say a great deal of time has been spent trying to determine the root cause of the crashes. One notion is that critical components and software failed due to improperly conducted risk analyses early in the design stage.
Qosina’s white paper discusses the criticality of updating your medical device risk analysis throughout the product lifecycle, conducting proper complaint investigation and designing for human factors.