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.…
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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 that, as a medical device company, you need to implement a QMS and be in compliance with FDA 21 CFR Part 820 and/or ISO 13485:2016.…

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ISO 9001:2015 and ISO 13485:2016 Are They Aligned?

With the release of ISO 9001:2015 and ISO 13485:2016, it’s time to explore their alignment.

Decades ago, when I first started working with industry standards, the concept of alignment didn’t arise often. There were not enough widely adopted industry standards to worry about alignment. But today we are moving in the right direction with the widespread – often required – use of global standards. Now we need to consider alignment when we compare revised versions of standards against their predecessors or related standards.…

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ISO 9001:2015 Changes Offer New Opportunities for Leadership Engagement

ISO 9001:2015 was published in September 2015. We are nearly a year into the transition period for ISO 9001:2015, and affected organizations are busy assessing the gaps between their current processes and ISO 9001:2015’s requirements.

Common gaps include several areas related to input from top management. Although addressing these requirements will take some effort, they provide opportunities to increase top management’s engagement in the quality management system.

New Requirements for Top Management in ISO 9001:2015

ISO 9001:2015 Requirement: Context of the Organization (Clause 4)

Clause 4 sets the stage for the management system.…

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