Bioinstrumentation

Biomedical instrumentation or Bioinstrumentation  focuses on the development of methods and devices for the treatment of diseases. It is an emerging field of biomedical engineering that bridges the gap between medicine and engineering. It combines the design and problem solving skills of engineering with medical and biological sciences to advance health care treatment, including diagnosis, monitoring, and therapy.  To ensure that good quality assurance practices are used for the design of medical devices and that they are consistent with quality system requirements worldwide, the Food and Drug Administration revised the Current Good Manufacturing Practice (CGMP) requirements by incorporating them into the Quality System Regulation, 21 CFR Part 820.


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