Post Marketing Surveillance For Medical Device
Post Marketing Surveillance (PMS) is the practice of monitoring the safety of a medical device after it has been released on the market. Post Marketing Surveillance guidelines is a collection of processes & activities used to monitor the safety & effectiveness of medical devices. These activities are designed to generate information to quickly identify poorly performing devices & other safety problems & accurately characterize real-world device performance & clinical outcomes. The post-marketing surveillance includes the handling of the customer complaints, handling of the CAPA arising from the Customer complaints.
Post Marketing Surveillance services
include but not limited to the following
The CAPA system is the cornerstone of a Quality Management System, especially in the Pharmaceutical/Medical Device Industry, and the backbone and driver for Quality improvements. The CAPA system feeds the Quality System to improve processes, procedures, organization and business in a structured, well-documented and actionable way.