EU MDR requires all manufacturers to conduct advanced Post-Market Surveillance providing consistent information for devices already on the market. Article 83 of MDR states “For each device, manufacturers shall plan, establish, document, implement, maintain and update a post-market surveillance system in a manner that is proportionate to the risk class and appropriate for the type of device”. Manufacturers are required to actively and systematically gather, record and analyze relevant data on the quality, performance and safety of a device throughout its entire lifetime. This adds the burden on the manufacturers for updating their PMS systems, processes and add personnel to continually manage these requirements. With our help, your PMS reports become far more manageable for your team.
Our customizable solutions allow you to utilize our templates that are in accordance with regulation as well as your Notified Body requirements.