Part 2 of Top Regulatory Tips
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Tip 3: Quality systems should go in sooner rather than later
Qualtiy systems that grow with a company are always better developed and cost effective than those that are layered on during later stages. Personnel need to understand, on a deep level, the systems that go into designing and manufacturing processes. This is far easier to attain when quality systems are an ingrained, integral part of how your business operates.
Tip 4: Listen to the FDA
FDA is one of your most important customers but it can pretty difficult to hear what they have to say ... espeically when they have reservations about your product's intended use or design. Try to listen with an open mind and even if ultimately the suggested changes are not incorproated into your product, be sure that FDA understands how the design you've chosen addresses their concerns. Also, if FDA has decided that your product will be a Class III or PMA, it's not the end of the world. FDA, particularly OIVD, will work with you to clear this hurdle. Try to hear their decision as a challenge instead of an impenetrable road block.