Traditional safety assessment focuses on potential hazards from electrical, mechanical or other aspects of a design occurring during usage, while functional safety focusses on the reliability of the product to function safely and correctly in response to its inputs.

As more and more software used in medical devices, the associated risk of physical injury or damage (hazard) to the health and well-being of patients and operators who using them is increasing. It is critically important to ensure the safety, security and reliability of software.

STEMart provides functional safety testing to help manufacturer build safety into your medical device development process.