Trust Antmed for Your Medical Imaging Solutions

In the highly specialized and critical field of medical imaging, the quality and reliability of products are paramount. Medical facilities around the world are tasked with the responsibility of providing accurate diagnostics while ensuring patient safety. Antmed's commitment to these fundamental aspects has made it a trusted name in medical imaging solutions. Here's why Antmed stands out as a reliable provider of  medical imaging supplies in the industry.

Adherence to Global Standards

Antmed is dedicated to its philosophy of "Quality is Life," which is evident in its rigorous adherence to international regulatory standards. By strictly following EU EN ISO 13485, US 21CFR 820, and the Medical Device Single Audit Program (MDSAP), Antmed ensures that each of its products meets the highest quality and safety standards.

Key Certifications and Quality Systems:

- EU EN ISO 13485: This certification outlines the requirements for a comprehensive quality management system for the design and manufacture of medical devices.

- US 21CFR 820: Compliance with this part of the Code of Federal Regulations ensures that Antmed's products meet the FDA's requirements for medical devices.

- MDSAP Regulatory Requirements: Participation in MDSAP demonstrates that Antmed's manufacturing processes meet stringent international standards in multiple jurisdictions.

Comprehensive Quality System Certifications

Antmed has established comprehensive quality system certifications that encompass all aspects of its operations—from product development to post-market surveillance. This holistic approach ensures that every stage of the product lifecycle is governed by rigorous quality controls, aimed at ensuring the safety and effectiveness of its medical imaging solutions.

ISO 11135 Ethylene Oxide Sterilization Service Quality System

Sterilization is a critical process in the production of medical devices, particularly those used in imaging procedures where the risk of infection must be minimized. Antmed's ISO 11135 certification demonstrates its capability to provide high-quality ethylene oxide sterilization services, ensuring that all products are free from harmful microorganisms and safe for patient use.

Global Registrations and Certifications

Antmed's medical imaging solutions are registered and certified in dozens of countries, showcasing their global acceptance and compliance with various international medical device regulations. This wide range of product registrations is a testament to the universal trust and recognition that Antmed has earned. Some key registrations include:

- EU MDR

- US FDA 510K

- Health Canada

Coverage in Emerging Markets:

Antmed has also secured product registration certificates in critical emerging markets such as Brazil, Russia, India, Indonesia, and several countries in the Middle East and Africa, including Saudi Arabia, Egypt, and South Africa. This extensive footprint not only reflects Antmed's global reach but also its ability to meet diverse regulatory and market-specific requirements.

Conclusion

Choosing Antmed for your medical imaging solutions means partnering with a company that places quality at the forefront of its operations. The stringent adherence to international standards, comprehensive quality systems, and global certifications and registrations underscore Antmed's commitment to excellence. Whether you are a healthcare provider in the United States, Europe, Asia, or any other part of the world, you can trust Antmed to deliver safe, reliable, and high-quality medical imaging products that meet the needs of today's complex healthcare environment.