Medical device manufacturers are facing more FDA scrutiny of their quality systems than ever before. In the last decade, the quality systems elements with the most FDA observations have consistently been P&PC, CAPA and Design Controls. In 2017, P&PC and CAPA subsystems alone accounted for 34% and 33%, respectively, of the total 483 observations issued by the FDA, followed by Design Controls with 13%.
Most quality leaders don’t work in businesses with a quality first mindset. Surveys and research show that certain roadblocks are common for quality professionals across industries. Building awareness of the major challenges you’re likely to face and using a few clever strategies to handle them will help you dodge compliance risk and keep quality standards high.
by Federico Perez, Senior Quality and Compliance Manager
Today, most medical device manufacturers (and most organizations in general) don’t think of quality as an aspect of company culture. It is seen as one department’s responsibility. For some, the only time leadership really dives into questions of quality is when there’s a problem. Especially a problem that could impact market reputation or increase attention from regulatory bodies.
October 5, 2016, Posted by Randy Gasa