QMS Auditing

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Objective assessments of QMS effectiveness against regulations and internal procedures:  Regal Intel conducts thorough and objective internal audits of your quality management systems to assess compliance with relevant regulations, standards (e.g., ISO 13485, FDA 21 CFR Part 820, 210, 211, 351, 361, ISO 9001), and internal procedures. Our audits identify areas for improvement, ensuring your QMS is effective and aligned with your business objectives. We provide detailed reports and recommendations to help you enhance your processes and maintain compliance.

Evaluating and managing supplier quality and compliance:  We help you effectively evaluate and manage your suppliers through comprehensive audit programs. Our audits assess the quality and compliance of materials and services throughout your supply chain, minimizing risks and ensuring consistent product quality. We work with you to develop tailored audit plans and provide clear, actionable feedback to your suppliers.

Preparing your team for FDA, Notified Body, and other regulatory inspections:  Prepare for regulatory inspections with confidence. Regal Intel conducts thorough pre-assessment audits and realistic mock inspections to identify potential gaps and areas for improvement. Our services are designed to simulate regulatory inspections by agencies such as the FDA and EMA, helping you understand your readiness and mitigate risks.

Leverage the efficiency and flexibility of remote audits. Regal Intel utilizes advanced technology to conduct effective audits without the need for on-site visits. Our remote audits provide valuable insights and assessments, offering a cost-effective solution for maintaining compliance and monitoring your QMS.

• Expert Auditors: Our team comprises experienced auditors with in-depth knowledge of global regulatory requirements.
• Objective Assessments: We provide unbiased and thorough evaluations of your QMS.
• Tailored Solutions: Our auditing services are customized to meet your specific needs and industry requirements.
• Actionable Insights: We deliver clear, actionable recommendations to drive continuous improvement.
• Global Compliance: We help you navigate the complexities of international regulations.