fda audits on devices

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Virgilio Vinas, MD, MPH, PhDCEARA, LLC

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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