Do you have a device where failure would be reasonably likely to have serious adverse health consequences or the device is intended to be implanted in the human body for more than one year or the device is intended to be used to support or sustain life and to be used outside a user facility? Then chances are you will be required to conduct a post-market surveillance study on your device in order to collect data that may reveal unforeseen adverse events, the actual rate of anticipated adverse events or any other information that is necessary to protect the public health. The request may come from the FDA at any time during the review of your marketing application, as the device goes to market, or after your device has been on the market for a period of time. 
 
 
GEMAR can:
 
 
  • Assist you with the design of the post-market surveillance plan

  • Ensure that the plan is initiated in a timely manner

  • Ensure that the data identified in the plan is collected

  • Submit the reports to the FDA along with any additional required data.

 
 
Contact us for further information.