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. A typical, basic requirement is that no single failure should cause the therapy to become unsafe at any point during its life-cycle. See safety engineering for a discussion of the procedures used to design safe systems.
Many biomedical devices need to be sterilized. This is a unique set of problems, as most sterilization techniques can cause damage to machinery and materials.
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 less expensive, yet accurate.
Regulatory issues are never far from the mind of a biomedical engineer. To satisfy regulatory issues, most biomedical systems must have documentation to show that they were managed, designed, built, tested, delivered and used using a planned, approved process. This is thought to increase the quality and safety of the therapy by reducing the likelihood that needed steps can be accidentally omitted.
There are two basically different regulatory frameworks.
In the U.S., the Food and Drug Administration adopts an adversarial position. It actively regulates individual devices and drugs, and assumes that new therapies are both unsafe and don't work until proven otherwise. This is known to create a bottleneck in the development process, and this has been quantified and costed by comparing approval times in the U.S. to approval times in Europe. The Life Extension Foundation (an interested civil action group, see www.lef.org) and Reason foundation (another interested civil action group, www.reason.org) have indpendently estimated that the FDA has killed hundreds of thousands of people, years earlier than necessary, by delaying new therapies. If so, the FDA has thus destroyed more U.S. citizens' life than any war ever fought by the U.S.
In the European common market, and many other areas, regulatory organizations are licensed by the government, which inpects amd approves regulators. This is similar to the method used in the U.S. and Canada to certify electrical devices for fire-safety.
In this system, a medical device company hires a regulator to obtain approval of a biomedical device. The medical company and regulator then work together to assure that the device or drug is safe. Efficacy is considered a matter for doctors and medical services to address. Consumers or their insurance company can sue both the medical device company and regulatory company, if they can show that legal standards of safety were not met. This gives the companies reason to follow those standards.
There is no bottleneck because the regulators are directly paid by the medical device company
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