The international standard EN ISO 14971:2009 – Application of Risk Management to Medical Devices has been amended to its next version EN ISO 14971:2012. The new version requires significant changes to the existing practices of risk management and has a considerable impact on medical device manufacturers. The revised standard has shown greater harmony with European medical device directives. More importantly, requirements of the essential requirements checklists that in many ways contradicted the clauses of ISO 14971: 2007 have now been addressed through this transition.
This paper includes a deviation table that explains the changes made to the existing standard, and also the way existing clauses have been interpreted. HCL has technically understood the changes and developed its process flow to support its clients, to implement these changes in a faster, economical, and more effective way. Since the flow is very generic, different clients can easily adapt and integrate this with their existing systems.
