Among the most important changes, the paper points out, is one that defines what clinical data can be used to demonstrate safety and performance. Clinical trial testing is one option, though it requires a lengthy, expensive process. An alternative is a clinical literature review of published data for similar devices. In fact, conducting the literature review should be the first step to discovering whether an appropriate comparison can be made or whether the company needs to engage in a more expensive meta-analysis or an even more costly, time-consuming clinical trial.
Dr. Schenberger (http://www.nerac.com/meet_our_analysts.php?id=72&page=8), who brings nearly two decades of industry and academic insight and experience to helping medical device companies achieve product approval through FDA, ISO and CE registration processes, has successfully submitted multiple medical devices to Notified Bodies for approval. She also has written numerous clinical literature reviews on behalf of Nerac clients, and all her reviews were approved by the clients' Notified Bodies. Mr. Bafan (http://www.nerac.com/meet_our_analysts.php?id=65&page=1), who has an academic background in biomedical engineering and a professional background as a business development and operations manager, is experienced in business strategy and hands-on research specific to the commercial biomedical and medical device industries.
Nerac Inc. (http://www.nerac.com) is a global research and advisory firm
for companies developing innovative products and technologies. Nerac Analysts
deliver custom assessments of product and technology devel
|SOURCE Nerac Inc.|
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