AUDITING SERRVICES
Internal Audit
Internal Audit
Our Internal Audit Services provide a comprehensive, independent, and objective assessment of your organization’s compliance with regulatory standards and internal policies. We ensure your processes and systems adhere to industry regulations such as FDA, MDR, MDSAP and ISO 13485.
Our audits encompass all aspects of your operations, from manufacturing to documentation, with a thorough evaluation of your quality management system (QMS). We identify areas for improvement and non-conformances, offering detailed recommendations and actionable insights to enhance compliance and operational efficiency.
Our goal is to maintain the highest standards of quality, ensuring continuous improvement and robust regulatory compliance within your organization.
Supplier Audit
Internal Audit
Our Supplier Audit Services assess the quality and reliability of your suppliers to ensure they meet your standards and regulatory requirements. We perform rigorous evaluations of their processes, quality control measures, and compliance with industry regulations. By identifying potential risks and areas for improvement, we help you maintain a robust supply chain, mitigate risks, and ensure the consistent quality of your products.
External Audit
External Audit
Our External Audit Services are designed to help your organization achieve and maintain regulatory compliance while preparing for official inspections by bodies such as the FDA and EU Notified Bodies. We offer a thorough and independent evaluation of your compliance with industry regulations and standards.
Our services include comprehensive audits covering all facets of your operations, including manufacturing processes, quality control measures, and documentation practices. By identifying non-conformances and areas for improvement, we provide detailed recommendations and strategies to address any gaps.
Our certified auditors have extensive experience with regulatory requirements and inspection processes. We guide you through the preparation for official inspections, ensuring your organization meets the stringent standards set by regulatory authorities.
By partnering with us, you can confidently navigate the complexities of regulatory compliance, minimize risks, and ensure your organization is fully prepared for any official audits or inspections.