For similar versions of the same device, 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:
Design controls are one of the core processes of the overall quality management system (QMS) mandate, and the presence, completeness, and accuracy of your DHF go a long way towards helping you pass your next FDA audit. 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.”ĭHF is primarily an organizational tool meant to show that the design controls process was properly followed and documented throughout product development while the majority of the medical device compliance regulations enforce the establishment of policies and procedures for enforcing quality standards. Each manufacturer shall establish and maintain a DHF for each type of device. Medical device companies should consider the quality system regulations as their “key to admission” into the medical devices marketplace.ĭesign history file. For example, Class I medical devices (with some exceptions) are exempt from the design controls portion of the regulations, but in general, the guidelines must be satisfied to permit the sale of a medical device within the United States. Differently classified medical devices may have different requirements under the quality system guidelines. The FDA’s mandate for quality systems states that each medical device company must establish and maintain a quality system that meets the requirements of its regulations and is appropriate for the medical device they manufacture. The DHF was the last step in the design controls process mandated by the FDA in 21 CFR Part 820. It contains all of the product development documentation pertaining to a finished medical device. In 1990, the FDA mandated the design history file (DHF) as part of the safe medical devices act.
#CAPA PROCESS STEPS CODE#
The food and drug administration(FDA) quality system requirements for all medical device companies are documented in the federal code of regulations, under 21 CFR part 820.
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