Work with the Regulators, Not against them |
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| Written by Graham Stoney | |
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I probably don't need to tell you that it makes no sense to pick a fight with a regulator or auditor; but I know companies that have gone down after doing so, so I'm going to say it anyway. The best way to deal with a regulatory agency is to align your goals with theirs. Medical industry regulators have a duty to the public to ensure that the devices on the market are safe and effective. If you don't have the same goal of safety and effectiveness for your customers, then the medical industry isn't for you. Treat the regulator as though their job is to help you succeed in helping your customers in the safest, most effective way. In fact, some of the regulatory guidance documents say that this is exactly how they see their role; they are not nasty highway cops intent on stopping your business speeding down the highway of success. If you have a personal problem with authority, this isn't the forum to exercise it. Auditors have a wealth of experience to offer you, if you are prepared to listen to what they say and don't get all defensive when they see something they don't like about your development process. Social Bookmark this page:         
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