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HCL Technologies

Medical Device Risk Management Transition

Medical Device Risk Management Transition

The international standard EN ISO 14971:2009 – Application of Risk Management to Medical Devices has been revised to its next version EN ISO 14971:2012. The revision requires significant changes to the existing practices of risk management and has considerable impact on medical device manufacturers. The revised standard has shown greater harmony with the European medical device directives. This paper includes a deviations table that explains the changes made to the existing standard and also the way existing clauses have been interpreted differently. HCL has technically understood the changes and developed its own process flow to support its clients in implementing these changes in a faster, economic and effective way. Since the flow is very generic in nature, different clients can easily adapt and integrate this with their existing systems.


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