ISO 14971:2007 is a state-of-the-art, international standard that is quickly being recognized as the best process to ensure that all aspects of risk management are considered throughout the product lifecycle for medical devices.
ISO 14971 for the application of risk management is designed to help manufacturers introduce safe medical devices into the market place. The manufacturer is responsible for identifying and controlling not only the risks associated with their medical device, but evaluating interactions with other devices. The standard also allows for other healthcare manufacturing organizations to use the process [and obtain certification]. This might include human tissue, animal care products, pharmaceutical manufacturers, etc., who may choose to use this standard.
The standard requires that top management demonstrate its commitment to risk management by; a) establishing the process, b) setting the policy for acceptable risk, and c) reviewing the effectiveness of the process at determined intervals. The risk management certification program by BSI will bring focus to this aspect of the process, and ensure that the manufacturer understands any significant gaps in the organization’s process.
The BSI ISO 14971 Risk management certification program was created by a team of Healthcare experts specializing in the needs of Medical Device Manufacturers and meets the latest 2007 requirements. The standard recognizes that even though medical devices are never without some level of risk, manufacturers still need a structured discipline to ensure that product benefits outweigh the risk, and that all risk has been reduced to an acceptable level. In addition it provides an excellent risk management model that focuses on the entire life cycle of the medical device.
