ISO Certified Manufacturing
International Organization of Standardization (ISO) establishes the quality management system guidelines for the manufacturing of medical equipment. UVLrx Therapeutics Inc. has earned ISO 13458 certification for its stand-of-the-art facility in Florida, USA. Our certification and exceptional team of engineers and assemblers ensure that the highest quality of medical equipment is designed, assembled, and maintained.
Non-Significant Risk Determination
The Food and Drug Administration (FDA) has established basic guidelines to determine the overall risk of a medical device: significant risk or non-significant risk. A medical device manufacturer must present clinical data to institutions like the FDA or independent review boards (IRBs) to assist them in determining the risk of a medical device. The UVLrx Treatment System™ has been awarded a non-significant risk status in the United States.
UVLrx Clinical Studies
All studies conducted by UVLrx Therapeutics Inc. are in accordance with Good Clinical Practice (GCP) as required by the following:
United States (US) Code of Federal Regulations (CFR) applicable to clinical studies (45 CFR Part 46, 21 CFR Part 11, 21 CFR Part 50, 21 CFR Part 56, and 21 CFR Part 312); ICH E6; 62 Federal Register 25691 (May 9, 1997);
Good Clinical Practices
The CE mark is a European requirement for all consumer products to ensure they conform with specific standards and regulations relative to its primary purpose. The UVLrx Treatment System™ is manufactured in accordance with all relevant medical device standards and has demonstrated a strong clinical foundation. As a result, the treatment system has earned a comprehensive CE certification.