Quality and Regulatory

At Isoray, our people throughout the organization are dedicated and focused on producing cancer treatment devices that meet world class quality standards. Our commitment to the customers and patients will always be to provide a product that meets the required prescription, is safe and effective, and is delivered on time so that the battle against cancer can be effectively waged.

Our Quality System is designed to meet US Regulations and International Standards. We are a registered manufacturer with the FDA and hold multiple 510(k) clearances for Brachytherapy devices. We have a long-standing history of compliance to ISO 13485 and strive to exceed the requirements.

 

CE 538785 EC Certification
CE 539433 EC Certification
Certificate of Registration - ISO 13485-2003 FM 538470 05-11-2017