Selling your medical device in the global marketplace requires you to consider other languages and cultures. There are over 20 official languages in Europe alone and thousands more worldwide. How is it possible to provide necessary information about your medical device to a diverse group of users?
The use of symbols and the adoption of electronic labeling (e-labeling), where possible, help simplify product labeling while also providing sufficient information for users. In this white paper, we'll answer your biggest questions about standards, requirements, and symbols for medical device labeling, including:
You will learn all this and more in this 9-page white paper.
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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