Tuesday, January 18, 2011 10:17 AM
The QA/ RA Cheat Sheet
By Thomas Maeder
It is surprising how little many people in the medical device industry know about freely-, widely-available resources. Often, many do not know how easy it is to find the regulations and the preambles, or about the existence of Food and Drug Administration mailing lists, phone directories and databases. MedicalDeviceSummit presents a basic list of non-commercial regulatory reference links, most from FDA itself. Undoubtedly, we have missed some. Send us your suggestions to make this a ‘living, growing’ list.
Where do you find the information you need? Seasoned Regulatory Affairs and Quality Assurance professionals and those new to medical device regulations and procedures can appreciate a core library of bookmarked web sites that link quickly and easily to the right information. Many are unaware of Device Advice and CDRH Learn —both extraordinarily useful, readily accessible and highly reliable sources of information on all aspect of FDA regulation of devices. MedicalDeviceSummit more...
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