Medical Device Design Inputs, Outputs, Verification, and Validation. What Do They All Mean?

This is the second post in a 3-part blog series on medical device design control. We cover the basics of design control in our first post and look at DHR, DHF and DMR in our final post. We’ve also combined all three posts into one easy-to-read PDF, plus added some extras. Download it here. Earlier (in a previous post) we addressed the importance and necessity of design control planning. Now let’s talk about the specific design inputs that need to be […]

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Basics of Medical Device Design Controls: What, Why, and How

This is the first post in a 3-part blog series on medical device design control. In subsequent post we look at design inputs and outputs, and then DHR, DHF and DMRs. We’ve combined all three posts into one easy-to-read PDF, plus added some extras. Download it here. Coding changes. Materials substitution. Design refinements. UX improvements. Manufacturing changes. Medical devices, like all products and software, are constantly evolving. Yet, due to the nature of medical devices and their impact on personal health […]

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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 […]

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