Understanding Your Most Important Obligations in ISO 13485:2016 and the US FDA QSR

This is blog post 3 of 3 in our series on Medical Device Quality Management Systems. In our previous blog posts, we provided a high-level overview of medical device quality management systems, followed by a discussion on key components of a QMS that meets US FDA and EU requirements. In this final post we will take a look at key sections of ISO 13485:2016 and the FDA Quality System Regulations. We’ve combined all three posts into one easy-to-read white paper, plus added some extras. […]

Key Components of a Quality Management System that Meets US FDA and EU Requirements

This is blog post 2 of 3 in our series on Medical Device Quality Management Systems. In our previous post we talked about the basics of why medical device companies need to implement a QMS and the rules dictating these requirements. In this post we will talk more about key players and stages in the process. We’ve combined all three posts into one easy-to-read white paper, plus added some extras. Download it here. Key players in the quality management process We’ve established […]

Medical Device Quality Management System (QMS): What It Is, Where It’s Required, and Key Regulations to Know

This is blog post 1 of 3 in our series on Medical Device Quality Management Systems. If you already know the basics, skip to our second post on key components of a QMS. We’ve combined all three posts into one easy-to-read white paper, plus added some extras. Download it here. If you’re new to the medical device industry or simply need to brush up on quality system compliance, you probably have many questions that begin with what, where, why, and […]

The US FDA is Shifting Toward ISO 13485. But How Much and How Soon?

Earlier this month, the US FDA officially announced their intention to shift toward international harmonization of the US Quality System Regulation (QSR). The medical device industry is likely to give a collective thumbs-up to the proposal, although its impact is unlikely to be felt anytime soon. Known more formally as 21 CFR Part 820, the FDA QSR took effect in late 1978 and predates ISO 13485, which was introduced in 1996. The fact that FDA is nixing a regulation that […]

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