While doing some research about quality control for medical devices, I came across a FDA document which lists all kinds of barriers to quality control in the medical devices industry. They state three major challenges when improving the quality of a product. One of the challenges states ” Companies perceive that the regulatory framework is misaligned with assurance of quality outcomes, in that compliance with regulations does not ensure quality, and that current intervention practices may de-incentivize improved quality.”

Last week, we have been talking about regulations and how the government is also getting involved in regulation. Can that be a barrier with causing a failure to improve the quality of a product?

http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDRH/CDRHReports/UCM277323.pdf