文献类型： 会议论文

第一作者： P. Quin

作者： P. Quin ¹ ;

作者机构： 1.Sage In Vitro Fertilization, Inc, Cooper Surgical, San Clemente, U.S.A.

会议名称： Proceedings of the 13th World Congress on In Vitro Fertilization Assisted Reproduction & Genetics, Istanbul, Turkey, May 26-29, 2005

主办单位：

页码： 741-746

摘要： In the USA, the FDA has specific requirements published in the Code of Federal Regulations (21 CFR Parts 803, 806 and 820) dealing with complaints about medical devices, including ART media. Complaints that allege deficiencies related to the identity (ie labeling), quality, reliability, safety and performance of products have to be dealt with by the manufacturer. Complaints we have received can be grouped into the following areas: mi-crobial contamination, logistic problems (eg, shipping or order problem), poor clinical performance or customer QC test results, precipitation/particles in product, temperature of product on delivery, and pH problems. The frequency of complaints has decreased 2lA fold from 2003 to 2004. The proper handling of complaints has helped us improve the quality of our products and the customer service we provide.

分类号： Q344