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The new ISO 14155: a practical approach to your quality assurance system

机译：新版ISO 14155：质量保证体系的实用方法

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摘要

Changes in the updated version of the international standard for clinical investigations of medical devices - ISO 14155 (2011) - will pose a number of challenges for manufacturers conducting trials in Europe that have not previously focused on clinical investigations. The standard, which will essentially become a European "regulation" once the European Commission harmonises it by citing it in the Official journal of the ELI, will necessitate the reconfiguration of quality management systems and processes for companies to ensure they meet the new requirements. It is unlikely that there will be a transition period for the new standard. Although there is no fixed dated for its publication in the OJ, standards can sometimes be published five to six months after their release; therefore, the new standard could be published in the third quarter of 2011. In the US, the Food and Drug Administration is still deciding whether to recognise ISO 14155 or whether to handle it in another way.
机译：医疗器械临床研究国际标准的更新版本（ISO 14155（2011））的更改将对以前在欧洲进行临床研究的制造商构成挑战。一旦欧洲委员会在ELI的官方杂志中引用该标准，该标准实质上将成为欧洲的“法规”，它将需要重新配置公司的质量管理体系和流程，以确保它们满足新的要求。新标准不太可能会有过渡期。尽管在OJ中没有发布日期的固定日期，但有时有时可以在标准发布五到六个月后发布标准。因此，新标准可能在2011年第三季度发布。在美国，美国食品药品监督管理局仍在决定是否承认ISO 14155或是否以其他方式对其进行处理。

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