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HCL Technologies

EU MDR Compliance Approach

EU MDR Compliance Approach

The white paper describes an approach for implementation of new EU medical device regulation (EU MDR). The approach is developed by considering the impacts to change in regulations and best practices that the industry follows to implement when a new change occurs or changes to existing regulatory requirements or product standard is rolled out. The approach has considered the impact on low to high risk medical devices which be used by all medical device manufacturers, thereby allowing medical device industry to bring safe, effective and innovative devices to market quickly and efficiently.


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