Medical device manufacturers are facing mounting pressure to better manage the quality of their supply chain. One approach they’ve taken to improve risk management and increase efficiency is to partner with suppliers who are ISO 13485 certified.

For the 11th consecutive year, the Agency for Healthcare Research and Quality has released complementary reports that assess the U.S. healthcare system’s performance in the areas of healthcare quality, access, and disparities in care.

Not knowing the answer to the question posed in the title of this article has led many medical device manufacturers to undertake expensive and unnecessary retesting of their previously certified products.

Editor’s note: A webinar on this topic will held on May 29, 2014, at 2:00 p.m. Eastern / 11:00 a.m. Pacific. Register here.