Worldwide medical device QA/RA blog

News and commentary on regulatory changes.

As medical device quality assurance and regulatory affairs professionals, it can be challenging to stay on top of changes happening in our industry. Few people have the time to read lengthy articles these days and although many online newsletters exist, they are often packed with PR releases, ads or unrelated information. That is why we started this blog for QA/RA professionals in the medical device and IVD industry. The idea is to give you short updates on quality and regulatory topics that may be of interest to you.

Seis erros que certamente irão atrasar a sua submissão da FDA 510k

Em Julho de 2011, a Administração de Alimentos de Drogas dos EU (US Food and Drug Administration) conduziu uma análise dos seus dados relacionados ao 510(k) para determinar as causas do aumento nos tempos de revisão para liberação de dispositivos médicos. No estudo, a FDA identificou seis categorias de deficiências das quais considera questões de “qualidade” com as submissões para 510(k). Essas deficiências estão relatadas abaixo. Se o seu requerimento para 510(k) contém qualquer um destes pontos, o seu dispositivo médico provavelmente sofrerá atraso para ser liberado pela FDA.

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US Regulators to Exempt Some Class I and II Medical Devices from 510(k) Premarket Review

The US Food and Drug Administration plans to exempt certain medical devices from 510(k) premarket notification requirements due to what the agency considers their well-established safety and effectiveness.

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Europe Becomes More Vigilant About Vigilance

Under-reporting of incidents and general weaknesses in vigilance are no strangers to Europe's vast medical device regulatory landscape. In fact, this concept was addressed in this article.

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