Medical Equipment Design based on Risk Analysis: General Considerations

Medical equipment design, development, and manufacture are delicate processes that will result in certain level of risk involved in the use of the device. The main goal of risk analysis is to minimize hazards involved with the patient, the clinical user, and the environment. In this work, the main goal is to propose the general considerations for the design, development, and manufacture of medical equipment prototypes based on risk analysis. Several international standards are suggested to be applied. They are enforced by means of different tests for electromagnetic compatibility, electrical safety, and temperature hazards. If performed too late, a proper risk analysis may result in the re-design of parts or even the complete device. When we are aware of the risks that the prototype may be accompanied with, we can better prepare even for the tests that must be performed to prove the equipment complies with the international standards. Finally, the participation of a multidisciplinary group in all stages is highly suggested.