ABSTRACT
Medical device manufacturers have always been under scrutiny to ensure that their product does no harm to the patient. For many years, the focus has been on biocompatibility and sterilization. While these still remain important factors in the medical device approval process, regulatory agencies have become increasingly aware of the potential dangers of residual manufacturing materials on medical devices. A thorough validation of the cleaning processes used to remove residual materials from newly manufactured medical devices is necessary to ensure patient safety.
