How FDA Distinguishes Between Medical Device Servicing and Remanufacturing

Many medical devices eventually require preventative maintenance or repairs, and this vital service can be performed by a manufacturer, health institution, independent servicing organization (ISO), or third-party service company. In a 2018 report, FDA noted that their analysis of comments, complaints, and adverse events revealed that most serious issues were related to devices that had been “remanufactured” rather than instruments that had been “serviced.” The difference between the two may seem negligible, but it actually has profound compliance implications. Although […]

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Futureproofing Your Medical Device QMS for Global UDI Expansion

The Unique Device Identification (UDI) system was conceived as a means of harmonizing identification of medical devices throughout the distribution chain and at the point of use. UDI is required on labeling for Class II and III devices sold in the US (Class I enforcement begins September 2022), and you are likely aware that it’s coming soon under the EU MDR. Less commonly known is the fact that other countries and regions around the globe are also beginning to require […]

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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. 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 […]

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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. 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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