Quality Assurance, Certifications and Traceability

ISO 13485 Certification: Ensuring Quality at Every Step

ISO 13485 is an internationally recognized quality standard for organizations involved in the medical device industry. Our ISO 13485 certification demonstrates our unwavering commitment to meeting the highest quality and regulatory standards.

With ISO 13485 certification, we prioritize:

1. Product safety: We design and manufacture medical devices with patient safety as the top priority.
2. Stringent quality control: Our quality management system involves rigorous processes and controls, from raw material procurement to final product release, ensuring consistent quality and reliability.
3. Regulatory compliance: We stay updated on evolving regulations, delivering products that meet or exceed expectations.
4. Continuous improvement: We foster a culture of constant innovation to enhance our processes and products.

Meeting U.S. Regulatory Standards

We go a step further by being FDA-registered. This registration reflects our commitment to compliance with the U.S. Food and Drug Administration’s rigorous regulatory standards. It also signifies our dedication to ensuring that our products meet the highest safety and efficacy criteria, aligning with the FDA’s mission to protect and promote public health.

End-to-End Traceability: Ensuring Accountability

In addition to our certifications, we prioritize traceability throughout our operations. We implement comprehensive traceability systems that allow us to track and monitor every aspect of our products’ lifecycle. From the sourcing of raw materials to the delivery of finished medical devices, we can provide complete visibility and accountability, ensuring that our products are of the highest quality and integrity.

Commitment to Quality Assurance

At Acrotec Medtech, our commitment to quality assurance extends far beyond certifications and regulatory compliance. It’s embedded in our culture, driving us to continually innovate, refine our processes, and exceed industry standards. Our unwavering dedication to quality is a testament to our commitment to advancing healthcare and improving patient outcomes.

Continuous Improvement

We are dedicated to continuous improvement in all aspects of our operations, striving for excellence in quality, efficiency, and customer satisfaction. Through ongoing training, innovation, and collaboration, we remain at the forefront of the medical device industry, driving positive change and delivering value to our customers and stakeholders.

Choose Acrotec Medtech for quality, certifications, and traceability you can rely on. Our unwavering dedication to excellence is your guarantee of reliable, safe, and effective medical devices that make a real difference in patient care.