No manufacturer wants their product to go through a costly recall. However, the rate of medical device recalls is trending upward. The FDA reported the number increased by 97% between 2003 and 2012. That’s faster than the growth of the medical device industry itself. The FDA also reported that approximately 400 recalls per year could be prevented, when manufacturers address issues before their product ships.
Staying on the right side of compliance, quality, and your customers, requires rethinking old strategies. Medical device companies are shifting from a focus on compliance to a focus on quality. This shift means manufacturers are enjoying success by using industry leading product lifecycle management software.
To make sure you are not on the wrong side of the trend download the latest 2017 Axendia report: Managing Medical Devices Across The Total Lifecycle.