医疗器械单一审核方案(MDSAP)
医疗器械单一审核方案(MDSAP)
什么是MDSAP审核?
医疗器械单一审核方案（Medical Device Single Audit Program ，缩写为MDSAP）是由国际医疗器械法规论坛（IMDRF）发起，以ISO 13485为基础，结合五个参与国（美国、加拿大、巴西、澳大利亚和日本）的法规要求，由认可的审核机构进行一次审核满足多国法规要求的方案。
BSI可以提供MDSAP + ISO 13485 +UKCA+ CE的整合审核方案。
MDSAP审核由具备授权资质的审核机构（如BSI）进行。BSI已为大量世界领先的医疗器械制造商颁发了MDSAP证书。
MDSAP涵盖哪些地域和监管机构？
如果医疗器械制造商的产品出口涉及如下国家，可考虑进行MDSAP认证。加入MDSAP的五家监管机构已就如何执行和使用MDSAP发表如下声明：
MDSAP指南
全面了解MDSAP
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MDSAP认证服务手册 >
MDSAP is a way that medical device manufacturers can be audited once for compliance with the standard and regulatory requirements of up to five different medical device markets
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MDSAP七大审核流程的分析指南 >
Learn more about our training courses, available dates and booking options
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MDSAP网络研讨会 >
We offer a wide range of free and live webinars hosted by BSI Technical Specialists addressing key topics that affect your business including legislation, risk, and regulatory changes.
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医疗器械白皮书 >
Our white papers will help you understand how to perform better, reduce risk and make excellence a habit in your organization.
