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Had a lengthy response prepared, but deleted it after I "thought" I posted it. Think of a Med Device as a vanStall reel built in an aircraft shop with lots of extra engineers and managers around to support the FAA requirements as opposed to a Penn reel that just needs to meet specifications, it costs more just to keep the doors open. It probably takes a couple of years of developing a document control system (with associated staffing and outside 3rd party audit assistance) that can pass a FDA audit. Tightly controlled processes that are documented to prove you can make and measure products to spec, trial runs of unsaleable parts using production resources. FDA auditing you as a manufacturer every couple of years tying up your staff for days or weeks and possibly fining you. Maintaining device history records securely for the "life" of the product.. Some medical devices are made in 10's to 1000's rather than multiple millions..
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