医疗器械单一审核程序MDSAP(Medical Device Single Audit Program (MDSAP)是由国际医疗器械监管机构论坛(IMDRF)的成员共同发起的项目。 旨在由具有资质的第三方审核机构,对医疗器械生产商进行一次审核即可满足参与国不同的QMS/GMP要求。 该项目已经获得五家监管机构美国食药品监督管理局FDA,加拿大卫生局 Health Canada,澳大...
神通医疗通过医疗器械单一审核程序(Medical Device Single Audit Program,MDSAP )认证,并获得国际认证机构TÜV SÜD(TÜV南德)颁发的 MDSAP 认证证书。此次获证标志着公司质量体系同时符合ISO13485:2016标准以及美国(FDA)、澳大利亚(TGA)、巴西(ANVISA)、加拿大(HC)、日本(MHLW)五国国家监管机构的要求,认证范围包括脑...
注射器MDSAP质量体系文件 MDSAP(Medical Device Single Audit Program)质量体系文件是指制造商为获得MDSAP认证而需要准备和维护的文件和记录。MDSAP的质量体系文件要求通常包括以下内容:质量手册(Quality M...
TUV USA offers the MDSAP (Medical Device Singles Assessment Program) is to achieve a common audit standard which takes the different regulatory requirements of national approval bodies into consideration.
Le Medical Device Single Audit Program (MDSAP) permet un audit unique du système de gestion de la qualité (QMS) d'un fabricant de dispositifs médicaux, qui satisfait aux exigences de plusieurs juridictions réglementaires. Les audits sont menés par des organismes d'audit (AO) tels ...
This course will help you prepare an MDSAP audit and allow you to determine if your own internal QMS processes are consistent with the requirements of MDSAP.
United States– U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health will accept the MDSAP audit reports as a substitute for FDA routine inspections. Medical Device Single Audit Program process Similar to other management system audit programs, MDSAP is based on ...
The Center for Devices and Radiological Health (CDRH), a branch of the FDA, accepts MDSAP audit reports as a substitute for FDA routine inspections (every two years, according to established procedures). [Medical Device Single Audit Program (MDSAP) Frequently Asked Questions, Version 016 of Augus...
The Medical Device Single Audit Program (MDSAP) is a harmonised approach to auditing and monitoring the quality management systems of medical device manufacturers on an international scale.
Class I, II, and III medical devices, including Premarket Approval (PMA) products Class 7 and Class 8 cleanroom controlled environments US FDA 21 CFR Part 820 compliance Canadian Medical Device Conformity Assessment System compliance Medical Device Single Audit Program (MDSAP)BioProcessing...