【EXPERT Q&A】What is CAPA for Medical Devices?
May 6, 2024
Source: drugdu
169
Drugdu.com expert's response:
Corrective and Preventive Actions (CAPA) in medical devices refer to a series of measures taken in response to identified issues or defects. CAPA aims to ensure the safety and effectiveness of medical devices and compliance with regulatory requirements. These measures include:
1.Corrective Actions: Steps taken to address existing issues or defects, aimed at eliminating or correcting their root causes to prevent recurrence. This may involve repairs, improvements to product design, or enhancements to manufacturing processes.
2.Preventive Actions: Measures taken to address potential issues or defects, intended to prevent future quality problems. This may include improving product design, updating manufacturing processes, or enhancing training.
CAPA is an essential component of the quality management system for medical devices, often detailed in standards such as ISO 13485. Implementing CAPA helps ensure the safety, effectiveness, and quality of medical devices, while also ensuring compliance with regulatory requirements.
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