Preproduction Quality Assurance Planning: Recommendations for Medical Device Manufacturers

摘要

The safety and effectiveness of a medical device is established during the design phase of the device's life cycle. Manufacturers of medical devices should establish appropriate quality assurance procedures during this phase to assure that safety and effectiveness requirements are properly established and achieved in the device design before the design is released for manufacture. The document contains recommendations for the establishment of such a preproduction quality assurance program. Medical device manufacturers should consider implementing all or parts of the recommendations, as appropriate to ensure device safety and effectiveness.