SMART quality & compliance
CDRH Validation vs. CSV
“A goal without a method is nonsense.” — W. Edwards Deming What is CDRH Validation? In the USA, the FDA’s Centre for Devices and Radiological Health (CDRH) is responsible for regulating firms who manufacture, repackage, re-label, and/or import medical devices sold in the United States. THE CDRH also defines a validation approach for process and software for medical devices and radio-emitting products. There are 3 classifications of medical devices: Class I General Controls (with or without exceptions) Class II General Controls and Special Controls (with or without exceptions) Class III General Controls and Premarket Approval This classification implies a risk…
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