![]() ![]() ![]() ![]() Following the mandated design controls process closely will help you understand what documents are required, as each step generates its own documentation.īelow, we've listed the most important steps of the design controls process and what documents should be included with each step. Your DHF should contain all of the documentation created during the product development phase of your medical device. In the latter case, the materials would be stored in a software QMS and the DHF would be used to access them. This means that you could either create a folder that contains the required documents or create a document that acts as a reference sheet for the required materials. The DHF must either contain or reference the necessary documents.Your completed DHF reflects compliance with the design controls mandate and your design plan. ![]() Your design plan must reflect compliance with the design controls process and should be included as part of the DHF. The DHF demonstrates that the device was developed in accordance with both the design plan and the requirements of this part.If you make similar versions of the same device and the designs are the same, you can include all of the data in a single DHF. A DHF must be maintained for each type of device that you manufacture.Here are some key interpretations of the DHF guidance that medical device companies should take note of: The DHF shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of this part. Each manufacturer shall establish and maintain a DHF for each type of device. You'll have to refer to subsection j) for the specific text on DHF, but we managed to squeeze it in below: The design history file requirements live in 21 CFR Part 820.30, which contains the regulations for the design controls process. FREE RESOURCE: Make sure you know the key elements of your design history file with this free checklist. ![]()
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