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.
您可能已经听说,欧盟完善的医疗器械法规即将迎来变化。并且您可能有很多疑问。这些变化意味着什么,它们将如何影响您的公司? 欧盟新的医疗器械法规(MDR)将对医疗器械制造商进入欧盟市场的方式以及如何在产品的整个生命周期内维持合规产生重大影响。在这份长达28页的白皮书中,Emergo的
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