With the coming EU MDR, all manufacturers will require advanced PMS systems, processes, and personnel to manage these requirements. A medical device Post-Market Surveillance system should provide consistent information for devices already on the market. It is the key function to maintain your product is functioning correctly and at the highest possible safety level for users. With our help, adverse events become more preventable, and your PMS reports become far more manageable for your team.
Celegence can provide PMS guidance for your product from a global perspective. We specialize in major markets like the EU and the United States but have worldwide partners with expertise relevant to your needs. Our customizable solutions allow you to utilize our templates that are in accordance with regulation as well as your Notified Body requirements.