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Virgilio Vinas, MD, MPH, PhD CEARA, LLC

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Page 1: Fda Audits On Devices

Virgilio Vinas, MD, MPH, PhDCEARA, LLC

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4 Major Subsystems1. ManagementControls

2. Design Controls

3. Corrective andPreventive Actions

4. Production andProcess Controls

Linked To 3 Other Subsystems

5. Materials Control

6.Facility & Equip. Controls

7. Records/Documents/Change /Controls

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FDA Regulation of Medical Devices - PRWebww1.prweb.com/prfiles/2011/08/18/8729579/Basics of FDA Regulation...FDA Regulation of Medical Devices Ronda Balham, O.D. Presentation Outline

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Overview of FDA Compliance for Medical Devices - Glislandglisland.com/Pub/SampleSlides/Medical_Device_Compliance_US.pdf · Overview of FDA Compliance for Medical Devices ... defective,

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FDA Regulation of Medical Devices - 510(k510k.net/resources/...CRS+FDA+Regulation+of+Medical+Devices.pdf · FDA Regulation of Medical Devices ... Prior to and since the passage of