This paper was written to educate those involved with the design and manufacture of medical devices about some important changes that have been enacted by the FDA. Understanding the implications of these new regulations before they take effect will enable manufacturers to adjust their business plans and adapt accordingly. In short, manufacturers now bear responsibility for conducting risk management processes in compliance with applicable standards. It is our belief that working with qualified suppliers will improve a manufacturers’ ability to comply with these new quality systems and risk management requirements and help them maintain their competitive edge.
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