Regulatory Post Market Surveillance Process
It is called as medical device post-market surveillance (PMS), a system that provides continuous feedback about a device on the market in order to maintain a high standard of product quality. PMS is a regulatory requirement in major markets like Europe and the United States. The purpose of compliance is to ensure that the provisions of medical devices legislation are complied with after devices are placed on the market or put into service. It aims to ensure that non-compliant devices are removed from the market. Medical device manufacturers, as well as other firms involved in the distribution of devices, must follow certain requirements and regulations once devices are on the market.
Why E & E Medicals and Consulting?
Our post-market surveillance experts help in coordinating and investigating customer complaints to make an initial reporting decision, and ensure completeness and consistency of complaint and related documentation. We also conduct detailed analysis and reporting of post-marketing vigilance and surveillance on medical devices in the market.