This article was originally published in Summer of 2016's Made in PA issue, a publication of the Pittsburgh Technology Council.
The competitive landscape of medical devices combined with the advantages of being first to market often tempt manufacturers to move through the product development process at a rapid pace. Deficiencies in the production and process controls subsystem of the Quality System Regulation (QSR) accounted for 32% of the 483 observations cited in 2015.¹
Inadequate Design Controls accounted for 15% of the 483 observations in the same time period. It's no surprise that Warning Letters related to Quality System problems in 2015 often focused on those two areas, along with the Corrective and Preventative Actions (CAPA) subsystem.
A robust Quality System is certainly the first line of defense that device manufacturers must have in place not only to be compliant with Food and Drug Administration (FDA) regulations, but also to avoid costly mistakes during product development and beyond. Here are a couple of items to consider.