14^th Euro Biosensors & Bioelectronics Congress

Bioinstrumentation & Equipments

Biomedical engineering (BME) is the application of engineering principles and design concepts to medicine and biology for healthcare purposes (e.g. diagnostic or therapeutic). This field seeks to close the gap between engineering and medicine: 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. An important component of the revision is the addition of design controls.