How Do You Define Regulatory Compliance?

| 01 July 2011 | By Aastha Kohli, Shrenik Desai 

Form FDA-483 deficiencies or/and Warning Letters from the US Food and Drug Administration (FDA) are two of the least welcome things at a medical device firm. The number of Form FDA-483 deficiencies letters has crept up over the last few years. FDA has expanded its staff and decreased recipient response time to 15 days.1