Developing a Risk Management Strategy for Medical Devices in the US Market

Posted 01 November 2008 | By

Risk management is an essential component of regulatory compliance for medical device companies marketing their products within the US. Yet, since risk management requirements have evolved over the course of more than a decade, it is not possible for a regulatory professional to rely upon just one source to determine exactly what type of risk management system should be implemented to comply with US regulations. The best approach is to become knowledgeable about the information provided in many US Food and Drug Administration (FDA) and international documents before determining how to develop and deploy a risk management system that is both compliant with the requirements and appropriate to the risk-level of the company's products and processes.


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