What are Design History File Requirements?

What are Design History File Requirements? The Design History File (DHF) is a critical document for a medical device. The DHF is a record of a series of documents that explain the design history of a medical device. In other words, it is a documentation of the way by which the inputs that went into […]

List of DHF requirements

List of DHF requirements Which are the DHF requirements that the FDA looks for? DHF requirements are a very important part of the DHF. The DHF shows conformance with design controls as specified under FDA’s 21 CFR 820.30 and Sub-clause 4.4 of ISO 9001. It is meant to show that the inputs that were specified […]

Design History File content

Design History File content The design history file (DHF) is a very important document for a medical device, because it is what may be called the route map for the product’s design. It is proof that the device followed the right method on the way to arriving as the final product. What is DHF? It […]