Software Hazard Identification

Custom Software is critical and is an integral part of many complex medical devices. Some of these medical devices are high-risk medical devices as the failure can result in non-serious injury or serious injury or in some cases, even death for the persons using them. Because of this, the software contained in high-risk medical devices must be safe. To enforce this safety aspect, the regulatory requirements ISO 14971 and IEC 62304 that govern software development in medical devices establish the overall mechanism for risk management in the design and development of software for medical devices.

The main stages of software risk management consist of Risk Analysis, Risk evaluation, and Risk control.