Audit and Certification Services

Welcome to Safetek – Your Audit and Certification Partner. We ensure regulatory excellence and product quality.

Management System Audits

Our experienced auditors conduct thorough assessments of your management systems based on internationally recognized standards such as ISO 9001 (Quality Management System), ISO 13485 (Medical Devices - Quality Management System), and ISO 14001 (Environmental Management System). Through our audits, we evaluate the effectiveness and compliance of your systems, identify areas for improvement, and provide actionable recommendations to enhance your organizational performance.

Product Certification

We provide certification support to help you obtain regulatory approvals for your medical devices in various regions, including Brazil, Japan, USA, Australia, and Canada. Our experts guide you through the certification processes, ensuring compliance with the applicable regulations and standards specific to each market. We assist you in preparing the necessary documentation, conducting gap assessments, and facilitating communication with regulatory authorities.

Process Audits

Our process audits focus on evaluating the effectiveness and compliance of your manufacturing processes, quality control procedures, and risk management practices. We assess your adherence to relevant regulations, industry standards, and best practices to identify areas of improvement and enhance operational efficiency. Our auditors provide recommendations to optimize your processes, reduce risks, and enhance overall product quality.

Compliance Verification

Our services include verifying the compliance of your products with the applicable regulations and standards. We conduct thorough assessments and testing to ensure that your devices meet safety, performance, and quality requirements. Our experts assist you in understanding and implementing the necessary testing and documentation to achieve compliance and gain market access.

Continuous Improvement

We believe in the importance of continuous improvement to maintain regulatory compliance and meet customer expectations. Our consultants work closely with your team to develop customized improvement strategies, including corrective and preventive actions, root cause analysis, and performance monitoring. We support you in establishing a culture of quality and regulatory excellence within your organization.

Regulatory Updates

As regulations and standards evolve, it is crucial to stay informed and adapt your processes accordingly. We provide timely updates on regulatory changes and help you understand their implications on your management systems, products, and processes. Our experts offer guidance on incorporating regulatory updates into your compliance strategies, ensuring ongoing compliance and market success.

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