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Notified Body VS PMCF

Post market surveillance ( PMCF) is a part of Post market surveillance ( PMS)

Notified Bodies are insisting for proper controlled documentation for PMCF so manufactures are facing increasing pressures to provide detailed technical documentation.

This evidence should support any and all claims and indications regarding the device and residual risks. Well organized documents with correct justification and conclusions will boot the confidence of Notified Body about your Medical Device.

Secondly, the draft EU Medical Devices Regulations published in September 2012 incorporates MEDDEV guidance on both vigilance and PMCF are indicative of the laws that currently govern EU requirements, and there are continued legislative efforts to make PMCF and PMS an even more authoritative presence within the law.

This  approach aims at providing more transparency for the medical community and patients, working toward a better guarantee of long-term safety and performance
In addition to the broad commitment to improve delivery on the promise of long term safety and efficacy, industry trends have contributed to the need for a greater emphasis on PMCF.

We consultants will guide you through the enter process of PMC & PMCF process by developing procedure, Relevant templets, Review of documents and finally consolidation of data in a manner accepted by most of the notified Bodies.