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. Read Part 1 here. We’ve also combined all three posts into one easy-to-read PDF, plus added some extras. Download it here. Congratulations. 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. These specifications are typically […]

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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. Read Part 1 here. 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 defined and tracked. Of all the design control activities, developing a solid foundation of requirements is the […]

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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. 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 and safety, the entire product life cycle of a device must be carefully documented. It’s […]

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European Medical Device Importers and Distributors Have New Regulatory Responsibilities Under EU MDR Articles 13 and 14

When the European Medical Device Regulation (2017/745) was published in 2017, few medical device importers and distributors were aware of the new requirements that would be placed on them. Most of the compliance focus under the Medical Devices Directive (MDD 93/42/EEC) was squarely centered on manufacturers. In fact, the word “importer” only appears three times in the entire MDD and the word “distributor” does not appear at all! The EU MDR, however, elevates the importance of all economic operators, and […]

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