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A Design History File (DHF) is a document that describes the design history of a finished Medical Device. The DHF is a part of regulation introduced in 1990, when the U.S. Congress passed the Safe Medical Devices Act, which established new standards for Medical Devices that can cause or contribute to the death, serious illness, or injury of a patient. It is necessary to focus on two aspects of the definition:
Most of the Regulatory agencies have not specifically provided the exact document content requirements, but following are the high-level contents of a DHF, which are generally accepted by the agency reviewers or auditors along with other required elements:
Freyr makes it easier to compile your DHF or carry out DHF remediation, as per the requirements of target health agencies, like, the US FDA (21 CFR Part 820) or ISO certified notified bodies. The DHF regulations allow Medical Device companies to present their DHF as a document that references the product development documentation for your Medical Device.
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