A Device Master Record (DMR) is a collection of all the records that must be used to produce a medical device product. Let’s imagine that your medical devices company is planning on manufacturing a new and improved coronary stent, which is a Class III medical device....
Design Controls indicate that the medical devices your company makes are both safe and efficacious for the end-users. Let us say that your R&D department has come with a brilliant idea for a knee implant that will eliminate the disadvantages of currently available...
The Design History File (DHF) is a collection of documents that outlines the design history of a medical device. A DHF is one of the first documents that a regulatory body such as the FDA inspects for accrediting purposes. The primary function of the DHF is to provide...
A medical device quality management system (QMS) covers all aspects of your medical device’s life cycle. The purpose of QMS is to improve the quality of the medical device and related services, constantly meet customer and regulatory requirements. It is, therefore, a...
Post-market surveillance or post-marketing surveillance (PMS) is a regulatory requirement for manufacturers of medical devices that need to collect and evaluate the experience obtained from the devices placed in a particular market. For example, as a manufacturer of a...
If you are a manufacturer of medical devices and plan to market your product in either the US or EU markets, you must classify your medical device according to the edicts of the respective regulatory agency. The purpose of classifying your medical device is to...
