ISO 14971 is an internationally recognized standard for risk management for medical devices. It provides a systematic framework and guidelines for identifying, then evaluating, and ultimately mitigating risks associated with medical devices throughout their entire […]
Quality
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There are vital things to consider about your NC or CAPA record, and here is an easy reference guide. Ask yourself these questions about your record: Understanding the Description Understanding the Scope Understanding the Containment […]
Corrective and Preventive Action (CAPA) is a well-understood structured approach that professionals use to identify, address, and prevent issues, non-conformities, and deviations within processes, products, or systems. CAPA is commonly employed in various industries, including […]