By Debra Grodt, Director of Regulatory Affairs, Medical Device & Diagnostics, Novella Clinical What is a regulatory assessment? A regulatory assessment is a comprehensive review of Food & Drug Administration (FDA) regulations and similarly marketed devices to establish a framework to design a safe and effective product. Assessments include: a detailed rationale for product classification; […]
Novella Clinical
7 ways smaller cardiovascular companies can get to market quickly
For smaller CV device companies seeking to launch or expand their clinical research programs, this paper reviews seven areas of focus for the safest and most expedient path to market. This paper, from clinical research organization Novella Clinical, addresses key factors for smaller device companies to consider when bringing a cardiovascular product to market.
Seven steps to clinical trial success for small cardiovascular device companies
by Eric Distad, Senior Director, Medical Device & Diagnostics, Novella Clinical Heart disease remains the world’s number one killer. Fortunately, many innovative physicians and smaller device companies are helping to drive new product development in an attempt to better serve the increasing cardiovascular (CV) patient population. When it comes to marketing these new products, a […]