Highly regulated industries like biomedical engineering, life science, and pharmaceutical development are always at risk of an audit by a regulatory agency like the United States Food and Drug Administration (FDA). The last thing you want to worry about is the FDA or related regulatory body finding an issue with your compliance with regulations. Documentation, […]
Clinical evaluations and clinical investigations are two of the most critical parts of a medical device’s journey to mass marketing. Despite this being the case, there are frequent, widespread misconceptions of what each means. In this article, clinical evaluations, clinical investigations, and the processes, along with the requirements for each, will be discussed. What is
What Is The Difference Between Clinical Evaluation and Clinical Investigation? Read More »
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5 MDR Notified Bodies That Are Being Raised Right Read More »
