Non-Conformances and Corrective and Preventive Actions

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Ensuring consistent quality and compliance in the medical device industry is crucial. Our Non-Conformance and Corrective and Preventive Actions (CAPA) Services provide comprehensive solutions for identifying, addressing, and preventing non-conformances, ensuring your operations meet the highest standards of quality and regulatory compliance.

Our Services Include:

• Identification and Documentation: We help you identify and thoroughly document instances where products or processes fail to meet specified standards or regulatory requirements.

• Root Cause Analysis: Our experts conduct in-depth analyses to determine the underlying causes of non-conformances, enabling you to address issues at their source.

• Corrective Actions (CA): We develop and implement effective corrective actions to resolve non-conformances, ensuring they do not recur. This includes process adjustments, staff training, and system updates.

• Preventive Actions (PA): We design and establish preventive measures to mitigate the risk of future non-conformances, promoting continuous improvement within your organization.

• Regulatory Compliance: Our services ensure that your non-conformance and CAPA management processes comply with industry standards and regulatory requirements, including ISO 13485, MDR and FDA regulations.

• Training and Support: We provide comprehensive training and support to your team, ensuring they are equipped to manage non-conformances and implement CAPA effectively.