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Medical device manufacturers selling their products in Europe have a major impact on labeling operations due to the new EU regulation. The regulation will heavily impact on the current Quality Management Systems, Data Management & Regulatory compliance of the Medical industry. Several update requires detailed level of analysis, remediation by the qualified resources.Since HCL is a Strategic partner with many Medical device manufacturers & has a rich experience on handling similar regulatory compliance projects, HCL would like to emphasize & reinforce its commitment to be a successive business model.