ISO 13485:2016-certified

ISO 13485:2016-Certified Quality

At Marquis Medical, our commitment to excellence is backed by our ISO 13485:2016 certification—the internationally recognized standard for quality management systems in the medical device industry.

This certification confirms that our company adheres to the highest standards in the sourcing, handling, and distribution of medical imaging parts. It reflects our strict compliance with regulatory requirements, risk management protocols, and product traceability procedures—all tailored to meet the specialized demands of PET/CT systems.

What This Means for You

Reliable Quality: Every part we provide is managed under a system designed for safety, consistency, and performance.

Regulatory Compliance: Our processes align with FDA, EU MDR, and other international medical device regulations.

Customer Assurance: From order to delivery, our operations are structured to ensure transparency, accountability, and superior service.

Being ISO 13485:2016-certified is more than a mark of quality—it’s a promise to our customers that they’re working with a trusted, professional partner dedicated to supporting the highest standards in patient care.