The Department of Physics

Course Description

In the health sector, due to the inherent potential risk to life it is necessary to measure quantities as accurately as possible. The accuracy and reliability of medical measurements have direct consequences on each individual's health. In addition, medical decisions are often based on statistical analysis and on the conclusions of clinical studies. Medical measurements are incorporated within these studies and are correlated with other medical findings. Thus, the accuracy, reproducibility, and repeatability as well as the quality assurance (calibration, legal metrological control and reference measurement methods) of medical instrumentation must be assured. This course introduces the metrology and regulatory framework and standards of certain categories of medical devices.

This course comprises: metrology principles; quality in measurement and testing; the different international classification systems for medical devices; the life phases to developing medical devices; medical device design standards versus medical device operational standards; the regulatory framework for medical devices including the World Health Organization Medical Devices regulations; International Electrotechnical Commission standards for electrical equipment in medical practice and on medical device software; Examples of metrological characteristics (methods and equipment) for specific equipment such as, but not limited to, electrocardiographs. This course will be assessed through in-course assignments.

Assessment

Coursework 100%