FDA Presentation: ISO 13485 and Risk Management

FDA’s Quality System Expert Kim Trautman gave a presentation entitled ” ISO 13485, GHTF, MRA and Quality System Regulation Update”. The slides are at the link provided. They describe the status and direction and international standards related to global harmonization and the changes in ISO 9000. They also stress the importance of integrating risk management into the quality system.

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62304, FDA, and Emerging Standards for Medical Device and HealthIT
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