MedAccred and the FDA

MedAccred

一项行业管理的供应链监视计划,能降低患者安全风险、确保优质产品和符合适用于医疗器械生产的关键工艺的要求。欲了解更多信息,请与我们联系,或注册接收定期的计划新闻和更新。  

MedAccred and the FDA

09 July 2015

Since MedAccred was established, the MedAccred Management Council has pro-actively sought to keep the FDA updated on the program’s development. Briefings have been held with the Center for Devices and Radiological Health’s (CDRH) Office of Compliance and the FDA’s Office of Global Operations within the Office of the Commissioner. The program purpose and scope was discussed, along with the results of proof of concept audits which were conducted to demonstrate the program’s viability.

The FDA gave positive feedback and strong encouragement to pursue the development of the program. Further synergies were established between the FDA’s Case for Quality initiative (‘critical-to-quality’ methodology) and MedAccred, with MedAccred recognized as an important tool in assuring critical manufacturing process quality by ensuring flow-down of critical-to-quality specifications through the sub-tier supply chain.

The goal at this early stage of the program is to continue open communications with the FDA, providing updates on the progress of the program as appropriate. As the program continues to grow, MedAccred will also be starting to engage with other global regulatory bodies.

For more information, please contact MedAccred@p-r-i.org

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