What’s the Difference Between a Design History File (DHF), Device Master Record (DMR), and Device History Record (DHR)?

This is the last in a 3-part blog series on medical device design control. In the first post we talked about the basics followed by design inputs and outputs. We’ve also combined all three posts into one easy-to-read PDF, plus added some extras. Download it here.

Paperwork OverloadCongratulations. You’ve created all of your design inputs, defined the outputs, and conducted design verification. Your design is complete and you are ready for production. Now it’s time to make sure those design outputs are correctly translated into written production specifications.…

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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.

Fixing DevicesEarlier (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 defined and tracked.

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Understanding 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.

Men Working on Engineering Project

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 and safety, the entire product life cycle of a device must be carefully documented.…

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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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