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kak33 replied to the topic Discussion Topic: Is the DHF a living document? in the forum The Design History File 7 years, 2 months ago
I understand the idea of using the DHF as a living document to detail design and development plans and deliverables. However, at my company, once the product has been transferred, the DHF is sealed and any changes must be implemented via design change activities according to FDA Design Control regulations. From my understanding of regulation, ongoing changes to Device specifications, composition, formulation, component specifications, software, and labeling and packaging specifications should be reflected in the DMR.