Medical Device Design Control
Design Control (n.) | two birds…
A well-crafted medical device design control system can, in affect, “kill two birds with one stone.” Not only does a well-crafted system ensure an effective and efficient design process, but it builds each element required by the FDA into the process, automatically generating compliant documentation at the same time. But developing a comprehensive methodology can be time consuming in itself. Do you know what to build into your design process to be FDA compliant? How do you integrate those elements into your current quality management system (QMS)? And how do you convince senior management that putting good design control in place is time well spent?
A well-conceived design control methodology will return far more than it costs, by reducing the need for redesigns and enhancing customer satisfaction. But if you’re not sure of the difference between your DHF (design history file) and your DMR (device master record), your design input and your design output, your verifications and your validations, consulting an expert can help you put all the pieces in order—and the process in perspective.
AlvaMed design control experts are quality and regulatory professionals who also have years of hands-on experience as working engineers and engineering managers. No matter where you are in the design process, we can help you learn, train your people, and provide you with SOPs, forms and templates. Contact AlvaMed with your questions. We’ll show you just how far one stone can go.
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