Biomedical engineering

Biomedical engineering makes medical devices. It is different from other forms of engineering because it must be concerned more strongly with biological, safet and regulatory issues than other forms of engineering.

Most biomedical devices are either inherently safe, or have added devices and systems so that they can sense their failure and shut down into an unusuable, thus very safe state.See also safety engineering for a discussion of the procedures used to design safe systems.

Most biomedical devices are completely tested. That is, every line of software is executed, or every possible setting is exercised and verified. Most devices are intentionally simplified in some way to make the testing process cheaper.

To satisfy regulatory issues, most biomedical systems must have documentation to show that they were designed, built and tested using a planned, approved process. This is thought to increase the quality and safety of the device by reducing the likelihood that needed steps can be accidentally omitted.