Helping companies realize new and expanded product opportunities
Technology Expertise and the Clinical Evidence Report
A good Clinical Evidence Report (CER) is as unique as the product for which it is written. More than just a literature search (and there's no such thing as "just" a literature search), the CER includes an analysis of your medical device's safety & performance profile, comparison to the safety & performance profile of similar devices (if any) and discussion of your risk management and risk/benefit analyses. Together, these components in a well-written CER tell a complete story for the regulatory reviewer showing the expected clinical performance of your device. Click here for more.
From an opportunity analysis for a new medical device concept, to the nuts & bolts activities of product research & development, Medical Device Consulting can help entrepreneurs, start-ups and growing companies to bring their device ideas to life.
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