As the US Food and Drug Administration’s medical device and IVD review process becomes more complicated, partnering with an experienced FDA consultant can make a significant difference in your compliance efforts.
Whether your goal is to determine substantial equivalence for your medical device, implement a quality management system that complies with FDA Quality System Regulation, or obtain 510(k) premarket notification clearance, a skilled FDA consulting firm can assist you in your effort to meet all regulatory requirements.
Founded in 1997, Emergo Group has extensive experience providing FDA consulting to all sizes of medical device and IVD manufacturers seeking to bring their products to the US market. We have assisted medical device manufacturers worldwide with US FDA device classification, registration, representation and quality system compliance.
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