Laura Kelly

Device Master Record – What Is It, and Why Is It Important?

by Laura Kelly
The world of medical device design and regulations has a lot of abbreviations. We are going to focus on another of them in this blog – DMR. It stands for Device Master Record, but what is a DMR, why do you need one, what is included, and why is it important? What is a Device Master Record? A DMR is a file that contains everything that is needed to manufacture your medical device. It is a centralised record, so you don’t need a binder with all the documents included. Instead, the relevant documents can be referenced. You don’t need a...

What is a Design History File (DHF)?

by Laura Kelly
Documentation is an essential part of designing a new medical device, getting regulatory approval, and then maintaining compliance while the product is on the market. A crucial part of that documentation is the Design History File (DHF). There is a lot involved in creating and maintaining a DHF file. This blog provides an overview of the essential elements you need to know if you are about to begin, or are in the early stages of, designing a new medical device. What is a DHF? A DHF is a file of documents that outlines the design and development history of your...