CAPA consists of a specific set of actions that an organization must complete to resolve and eliminate recurring non-conformance. CAPAs are commonly used when medical devices are non-conforming. Let us say that your medical devices company is manufacturing lifesaving...
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...
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...
