5 Questions
Nov 20, 2012
Rita Hoffman is the managing partner RHoffman Inc. and has more than 36 years of FDA experience across the device, drug, and veterinary industries. Until...
Sep 28, 2012
CEO is usually the most high-profile job at any business, and medtech companies are no different. But what do they actually do, and how has the role changed...
Sep 07, 2012
Michael A. Santalucia is an independent regulatory affairs expert with more than 25 years experience in the medical device industry. We recently asked him to...
Jun 04, 2012
1. What is “Analytics”? Analytics examines raw data through the process of cleaning, preprocessing, modeling, and postprocessing with the goal to...
May 01, 2012
1. Why does FDA require validation of spreadsheets and databases? To put it simply, the purpose of validating any software or computerized system is to...