“Edwards Lifesciences is among the companies participating in the pilot program, and Rob Becker, director of quality at Edwards, said the MDDA audit that the company went through in 2017 ended up costing Edwards about $74,000 compared to a traditional compliance audit that would have cost closer to $140,000. What’s more, Becker said the process involved minimal business interruption compared to what the company was used to dealing with in the compliance audit process.”
https://www.mddionline.com/what-if-fda-and-medtech-worked-together-quality
Contact us at Two Harbors if you have questions or are interested in this program!
