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ajm73 replied to the topic Auditor's view of DHF / DHR in the forum Introduction to Design Controls 6 years, 5 months ago
In a DHF, all the documentation that went into preparing a product and designing it is contained. It contains all the neccessary documentation and proof that a product was made within spec of what was set out as well as within spec of regulating bodies. In essence, it is a history of how the product came to be what it currently is. In a DHR, all documentation and material relating to the manufacturing of the product is contained. This would include when the product was made, how many were made/sold, any device identifier (like GUDID), and more. In essence, it is a history of the production and life of the product at and after manufacturing.
Another important aspect of products to consider in the medical device development process is the Device Master Record (DMR). Contained within this is a record of every document and process relating to how to make and test the product in question. Things like product drawings, manufacturing processes for the product, quality procedures, packaging instructions. The DMR overlaps with the DHF greatly in what is referenced as much of it can also be produced and kept in the DHF as well.