Medical devices are among the most highly regulated products in the world today. A single functional failure can mean the difference between life and death for patients. The World Health Organisation has recommended that governments worldwide make national regulations for medical devices an integral part of their overall national health systems.
Ensuring the functional safety of medical devices is critically important for manufacturers, importers and resellers, as these devices can impact the health and wellbeing of the operators and patients that use them. By undertaking risk analysis and manufacturing medical devices that are functionally safe, your company benefits from increased market acceptance and positive brand associations. Failure to ensure functional safety can have dire consequences.