What is a DHF, and why do you need one?
DHF stands for Design History File, a cornerstone requirement by medical device regulators. Both the EU MDR and the FDA’s quality system regulations require medical device developers to maintain a record of the design of their device. The DHF contains documents that demonstrate that a device was developed in accordance with an approved design plan, as well as in agreement with applicable regulations. The regulations describing the DHF requirements for the FDA are contained in 21 CFR 820.30(j). It’s important to note that the DHF can also reference records instead of containing them - this allows your DHF to reference materials stored in an electronic quality system, for example.
Elements of a DHF
Since the DHF is what demonstrates that your product was developed according to its design plan and the applicable regulations, it’s critical that you include the design and development plan in your DHF. The design and development plan describes the device, how the device will be designed, and how the design will be verified and validated.
The DHF also needs to contain information on the design control process. This means including:
- Design inputs. This includes things like user needs of your device, the intended use, and indications for use. The design inputs will also be relevant for design verification. In the case of a software as a medical device, a software architecture and inputs/outputs structure outlined in IEC 62304.
- Design outputs. These include drawings, models, specifications, code, manufacturing instructions, or other documentation that is required for the manufacturing of the device.
- Design reviews. These periodic reviews of the design ensure that the design is progressing according to the design and development plan. Design review results are documented in the DHF, and are important for determining when to move to the next design phase.
- Design verification and validation. These activities demonstrate that your design outputs are appropriate for your design inputs, and that your device will perform as per its intended use. Approved verification and validation of your design are key points that must be achieved before transferring your design to manufacturing.
- Design transfer. This includes information necessary for the manufacturing of your device at scale, including any instructions that would be required for a new facility to start manufacturing your device.
At Nemedio, we know this can seem like a lot. See how Nemedio can help you with your DHF today!