PMS (Post Marketing Surveillance) activities consist of a process in which the performance and safety of medical devices are continuously monitored after the supply of products to the market. The necessity for post-market monitoring of a medical device begins immediately after the medical device is placed on the market.

The requirement for PMS Post-Market Surveillance of medical devices is specified in the Medical Device Directive MDD 93/42 / EEC (Annex 10) and the new regulation Article 83 of the 2017/745 / EU Medical Device Regulation. These directives require manufacturers to inform the Competent Authority of the information they obtain from the after-sales experience.

The after-sales surveillance system ensures the active and systematic collection of quality, performance and safety data throughout the life of a device, as well as recording, analyzing, interpreting, obtaining the necessary results, and implementing corrective and preventive actions.

Please contact us through kalite@egemen.com.tr to reach the PMS forms.