The Design History File (DHF), as an aspect of the Safe Medical Device Act, is an anthology of documentation and records, which pertains to the “design history” of finished medical equipment or product. In other words, DHF refers to both Device Master Record (DMR) and the technical documentation.
A DHF includes an index of documents and their storage location; a collection of original documents created in the PD (Product Development) process and other specifications. It is developed by the design control method – application of the traditional process to the handling of product development activities.
A Design History File is prepared as per the Regulatory requirements of the Agencies – which is a significant challenge for all the manufacturers and developers of medical devices. But how can you meet the agency’s requirements and prepare the DHF? Well, there are common challenges that developers face, which comprise:
● Maintaining the paper formats: Because the DHF needs to be updated and accurate, maintaining the paper formats is all the more necessary. The content needs to be appropriate; complete information and paperwork ought to be processed; proper signatures should be there.
● Overloaded DHF: Do not overload the DHF with costs, competitor analysis, or studies. Many companies tend to add all of this unnecessary information, which in turn doesn’t meet the end user’s expectations nor does it relate to the safety and efficacy needs.
● Disorganized mislead and misfiled documentation: when the documents are disorganized, the companies find it very difficult to find the appropriate information, which leads to product recalls. Hence, organize your DHF properly.
Now, what are the design control processes that are included?
● Design and Development planning: The developed design plan is to be incorporated.
● Design Input: Includes procedure to establish design input plans.
● Design Output Includes procedure to establish and document design output plans.
● Design reviews: Includes documentation with design reviews.
● Design Verification: Includes the validation process and approved results.
● Design Transfer: Includes the documented product specifications.
● Design Changes: Includes the design change process.
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