Medical Devices

Many medical devices are surgically placed in living bodies. For example, when manufacturing pacemakers, it is critical to manufacture them in a cleanroom that is routinely disinfected to eliminate harmful bacteria or pathogens to which a living body would be vulnerable. 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, and assurance that the Cleanroom in which the devices are manufactured meet the criteria for which they were designed in compliance with ISO 14644, Cleanrooms and associated controlled environments.