What Does FDA Registration, ISO/MDSAP 13485 Certification Mean?

At Source-Ray Inc., we are proud to be an FDA-registered, ISO/MDSAP 13485 certified facility. This distinction underscores our unwavering commitment to safety, quality, and innovation through continuous improvement.

When it comes to medical equipment, quality and regulatory compliance are paramount. At Source-Ray Inc., we are proud to be an FDA-registered, ISO/MDSAP 13485 certified facility. This distinction underscores our unwavering commitment to safety, quality, and innovation through continuous improvement.

Every product we design, develop, and manufacture reflects our commitment to adhere to the highest standards in the industry, ensuring quality, reliability, and trust for healthcare professionals and patients alike.

 What Does FDA Registration, ISO/MDSAP 13485 Certification Mean?

Being FDA-registered and ISO/MDSAP 13485 certified means we adhere to a rigorous quality management system. This system ensures that our products are consistently manufactured, tested, and inspected to meet stringent regulatory and statutory requirements. By implementing a risk-based approach and continuously improving our processes, we strive to exceed customer expectations while adhering to FDA and Notified Body guidelines 

 Our commitment to you:

• Adhering and Implementing Safety Standards: Rigorous testing ensures patient and operator safety in every use.

• Unmatched Reliability: Precision-engineered systems guarantee consistent performance in any clinical environment.

• Durability and Longevity: Manufactured in the USA with premium components to withstand demanding healthcare settings.

 Partner with Source-Ray:

Choose Source-Ray Inc., your trusted partner in X-ray equipment. Our FDA-approved products are designed to deliver precision, reliability, and exceptional performance.