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Clinical data and postmarket compliance under the MDR

postmarket Compliance

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 high standard of product quality. PMS is a regulatory requirement in major markets like Europe and the United States. Purpose of PostMarket compliance is to ensure that the provisions of medical devices. Legislation are complied with devices are placed on the market put into service. It aims to ensure that compliant devices are removed from the market. Medical device manufacturers, Other firms involved in the distribution of devices. Must follow certain requirements regulations devices are on the market.

To acquire this, we need a system of reporting in order that we are able to Gain feedback on our clinical devices. Which include reports of damaging events that involve them – we want publish-market surveillance (PMS). We additionally want to be reporting these events to the applicable regulatory bodies – they want to recognize that. We are taking the requisite steps to continuously enhance our commercial enterprise  production practices to keep away from recurrent problems with our devices.

Post-marketplace surveillance become mentioned in 2005 through the now-defunct Global Harmonization Task Force (GHTF). A voluntary group of representatives from medical device regulatory corporations  the regulated enterprise. A record become produced through GHTF which defined the unique obligations wanted for post-marketplace surveillance within the industry. Discussed how the requirements for every mission could be harmonized throughout regulatory environments. This file became later updated with the aid of the International Medical Device Regulators Forum (IMDRF) to problematic reporting suggestions for unfavorable activities.

Why E & E Medicals and Consulting?

Our post-market surveillance experts help in coordinating  investigating customer Postmarket compliance to make an initial reporting decision. Ensure completeness  consistency of complaint related documentation. We  conduct detailed analysis  reporting of post-marketing vigilance surveillance on medical devices in the market