Medical Device Postmarket Surveillance Requirements

If you are a medical device manufacturer and/or distributor, you are aware certain requirements must be followed after medical devices enter the market, such as reports of malfunctions and serious injuries or deaths, tracking, and registration of establishments where devices are produced or distributed. This is referred to as “postmarket surveillance.”

To assist you with medical device postmarket surveillance requirements, check out our carefully curated content on this topic.

• Postmarket Medical Device Surveillance at CDRH: Part I
  Redica Systems Senior GMP Quality Expert Jerry Chapman discusses the signals FDA looks at when a medical device is on the market.
• Postmarket Medical Device Surveillance at CDRH: Part II
  In Part II, Jerry Chapman covers how FDA CDRH officials would like medical device manufacturers to communicate with the agency when it comes to postmarket surveillance.
• The EU MDR and Postmarket Surveillance
  Two medical device experts examine EU Medical Device Regulation (EU MDR) requirements for postmarket surveillance.