European Union (EU) is a union of fifteen independent states based on the European Communities and founded to enhance political, economic and social co-operation.
ISO 14971: Risk Management Standard
In an effort to adopt enterprise-wide validation protocols and standards in the pharmaceutical and biotech environments, ISPE 14971 is considered to be the best document for overall risk management requirements. By April 2004, ISO 14971 will be the only standard for devices to meet risk analysis and risk assessment benchmarks in the European Union and possibly the US FDA. In practice, ISO 14971 is similar to the Quality System Regulation (QSR) with regard to risk management and includes post-production review. ISO 14971 is being integrated into technical standards for medical devices and is being looked at by other areas as a standard guide for risk assessment and risk management.
