A guide to ISO 13485 and CAPA for medical devices
Enhance product safety and regulatory compliance in the medical device industry by implementing robust CAPA (Corrective and Preventive Action) processes aligned with ISO 13485 standards.
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Strengthening medical device quality management through CAPA
This whitepaper provides a detailed guide to implementing a strong CAPA system as part of your ISO 13485-compliant quality management strategy. Learn how to structure an effective CAPA system using the 4 ‘I’s—Identification, Investigation, Implementation, and Internal Review—to reduce non-conformances, enhance product safety, and ensure continuous improvement.
Why you need this whitepaper
Unlock the benefits of a comprehensive CAPA system to ensure compliance, reduce costs, and improve product quality in the medical device sector.
Root cause analysis
Identify and address the underlying causes of non-conformances, improving process efficiency and reducing risk.
ISO 13485 compliance
Ensure your CAPA processes align with the globally recognized ISO 13485 standard to simplify compliance and regulatory demands.
Cost and time savings
Minimize reworks, recalls, and defects by maintaining a “right-first-time” approach to manufacturing and quality control.
Digital transformation
Understand how automation, AI, and IoT are revolutionizing the industry, improving operations and passenger experiences.