Many medical device manufacturers don't realize that Notified Bodies can perform unannounced audits of your quality system. They can even audit your critical suppliers with very little notice. In this whitepaper, we answer your biggest questions about Notified Body audits and how to reduce the potential for an unannounced critical supplier audit, including:
You'll learn all this and more in this 9-page white paper.
Alexandre Pétiard is a Senior Quality & Regulatory Consultant at Emergo. With more than eight years of experience in regulatory affairs, his expertise includes design control support, technical file preparation, clinical evaluation report, risk management file, 510(k), quality system implementation and audits, and post-market surveillance and vigilance activities. Mr. Pétiard previously held regulatory positions at Covidien, Integra LifeSciences, and Alcis.
在欧盟销售的医疗器械需要拥有一个证明其符合欧盟医疗器械法规的CE认证标志。CE标志表明法定制造商已评估器械,并且符合MDR 2017/745下的一般安全和性能要求(GSPR)。法定制造商将验证是否符合所有相关的欧盟要求,并必须在其欧盟符合性声明(DoC)中声明这一点。此外,高风险器械(MDR下
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