FDA Does Not Approve Napkin Sketches
If the medical device industry consisted of a ”who has the coolest and groundbreaking idea” contest, I would be a multi-billionaire based on the countless crumpled up napkins that litter my office. Part of falling far short of this financial goal is the realization that in a highly regulated industry, how a product is developed (and how that development is documented!), is just as important as the product idea itself. After all, part of FDA’s job is to ensure prospective patients remain safe during use of a medical device.
Although this concept is clear to me and other compliance consultants and professionals, some companies still struggle with the concept of design controls, establishing and maintaining a formal and objective methodology to develop a safe and effective medical device.
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