Are you marketing a wireless, networked, or interconnected medical device in the United States? If so, you can expect intense regulatory scrutiny from the US Food and Drug Administration (FDA).
The FDA pays special attention to cybersecurity vulnerabililties in medical devices, and has established cybersecurity control requirements for network, wireless, and similar technologies. Manufacturers must take extra measures to ensure the cybersecurity of their device throughout its lifecycle. In this white paper, we address your biggest questions about US regulatory requirements for wireless medical devices, including:
We answer all of these questions and more in this 4-page white paper.
自2022年5月26日始,欲在欧盟(EU)上市的新型体外诊断(IVD)医疗器械必须符合欧盟体外诊断医疗器械法规(2017/746 IVDR)。 同日起,带有有效CE标志的IVD可以继续按照指令98/79/EC(IVDD)进行销售,直至其许可证到期为止。 自2025年5月27日始,在欧盟销售的所
阅读更多要在欧盟合法销售体外诊断器械(IVD),您需要拥有证明其符合IVD法规的CE标识。CE标志表明合法制造商已经评估了器械,并且器械符合体外诊断器械指令98/79/EC(IVDD)的基本要求或体外诊断器械法规2017/746(IVDR)的一般安全和性能要求。合法制造商将验证它的器械是否符合所有相关
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