The extent to which stakeholders are able to tolerate risk is influenced by both of these factors, as well as their perceptions of risk. These concepts are particularly important when it comes to medical devices because stakeholders are involved in multiple ways-physicians, healthcare organizations, government agencies, industry organizations, patients, and the public.
As one of the stakeholders, the manufacturer should make a number of judgments about the safety of the medical device - including its acceptance of risk, taking into account the recognized level of technological development - in order to determine whether it is likely to be appropriate to place the medical device on the market for its intended use or intended purpose. This International Standard establishes a process by which the manufacturer of a medical device can determine the hazards associated with the medical device, assess the risks associated with those hazards, control those risks and monitor the effectiveness of the controls.
For any given medical device, other International Standards may require the application of specialized methods to control risks.
Auqida Medical Devices Consulting Organization