POSTMARKET COMPLIANCE

The purpose of compliance is to ensure that the provisions of medical devices legislation are complied with after devices are placed on the market or put into service. It aims to ensure that non-compliant devices are removed from the market. Medical device manufacturers as well as other firms involved in the distribution of devices must follow certain requirements and regulations once devices are on the market.

 

E & E Medicals will help to you maintain Post market compliance in the following ways;

 
  •  Medical Device Postmarketing Vigilance Reporting
  •  Help you respond to FDA 483s and warning letters
  •  Assist you Postmarketing Surveillance on your medical device while in the market.