Design History File

The intention of a DHF is to document the design history of a medical device starting with a device idea/concept and ending with a marketed device. The setup for this specific project is to provide a structured project approach to guarantee that all necessary steps have been taken to come to a final device ready for the market.

MDProject uses a project approach model to built up the design history of a product. The model requires input and commitment from various disciplines and follows the product development cycle. For each phase in the DHF product development cycle, deliverables are set focusing on specific requirements needed to be able to come to a smooth product registration and market approval.